Les meilleurs esprits scientifiques
travaillant de concert pour faire avancer
la mise au point de médicaments

SATURDAY, May 8th, 2021
2pm to 5pm

What is Speed Interviewing:

Speed Interviewing is a virtual career fair, which is taking place on Saturday May 8th, 2021 Candidates will submit their resume via the CellCarta Career Page and the selected applicants will be screened / interviewed through Microsoft Teams by an HR representative. 

Available Positions:

• Research Assistants
• Principal Scientists
• Group Leaders
• Technicians - Flow Cytometry

Step by Step Process:

Step 1: Submit resume via Caprion’s Career Page.

Step 2: Selected candidates will receive an email from an HR representative with a time (20mins) for an initial screening via Microsoft Teams.

SAMEDI 8 mai 2021
14h à 17h

Qu’est-ce que l’entrevue éclair:

L’évènement entrevue éclair est un salon de l’emploi virtuel, qui se déroule le samedi 8 mai 2021, de 14h à 17h. Les candidats devront soumettent leur curriculum vitæ sur la page Carrière de CellCarta et les candidats sélectionnés seront présélectionnés/interviewés par un représentant de CellCarta sur Microsoft Teams.

Emplois disponibles:

• Assistants de recherche
• Chef d'équipe quart de jour et quart de soir
• Scientifique Principal
• Technicien - Cytométrie en flux

Déroulement:

Étape 1: Soumettez votre curriculum vitæ via la page Carrière de Caprion.

Étape 2: Les candidats sélectionnés recevront un courriel d’un représentant des RH pour céduler l’entrevue avec les RH. Celle-ci durera 20 minutes.

Étape 3: Si la présélection auprès du représentant des RH est réussie, le candidat rencontrera alors directement le gestionnaire en entrevue sur MS Teams toujours.

_____________________________________________________________________________________

The Quality Control Reviewer incumbent will perform quality control activities which are relevant to his/her field of expertise and linked to assigned projects. 

Key Responsibilities

• Review data (tables, forms, calculations, etc.) and reports, as assigned;
• Report findings to immediate supervisor to identify improvement opportunities;
• Help in implanting good quality control practices;
• Prepare the documentation to be transferred to the archives at the end of a project;
• Complete tasks in compliance with GLPs, driving documents, and current procedures.

Education

• B.Sc. in Biosciences (or a related field).

Required Experience and Skills

• Strong attention to detail
• Knowledge of the GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) regulations
• At least 1 year of equivalent experience
• 1 to 2 years of work experience in the biopharmaceutical industry
• Basic scientific knowledge in biochemistry and immunology
• Bilingualism – Verbal and written in French and English
• Knowledge of Microsoft Office programs, specifically Word and Excel
• Good organizational skills and ability to prioritize
• High degree of initiative, sense of urgency and flexibility

Le technicien de contrôle qualité est chargé d’effectuer une variété de tâches liées au contrôle de la qualité.

Principales Responsabilités

• Vérifier les données (tableaux, formulaires, calculs, etc.) et les rapports;
• Transmettre les résultats au superviseur immédiat afin d’identifier les occasions d’amélioration;
• Participer à la mise en œuvre des bonnes pratiques de contrôle de la qualité;
• Préparer la documentation à transférer aux archives à la fin des projets;
• Effectuer les tâches conformément aux BPL, aux normes et aux procédures en vigueur.

Éducation

• Baccalauréat en biosciences (ou un domaine connexe).

Expérience et compétences requises

• 1 à 2 ans d’expérience professionnelle dans l’industrie biopharmaceutique
• Au moins 1 an d’expérience en contrôle de la qualité
• Connaissance des BPL (bonnes pratiques de laboratoire) et des BPC (bonnes pratiques cliniques)
• Connaissances scientifiques de base en biochimie et en immunologie
• Bilinguisme (français et anglais, oral et écrit)
• Connaissance des programmes de la suite Microsoft Office, notamment Word et Excel
• Souci du détail
• Bonnes compétences organisationnelles et capacité à prioriser
• Forte capacité d’initiative, sens de l’urgence et faire preuve de flexibilité

Summary

The IT support technician will provide level 1 technical support to all User requests and will maintain the functionality of the workstations, phone system and software.

Main Responsibilities

• Provides Level 1 Technical Support for all User requests
• Provides support during and outside of business hours (on-call)
• Provides support for corporate cell phones and VOIP systems / phones
• Provides technical assistance and training to Users
• Performs the installation, updating and maintenance of software, workstations or other devices
• Installs and configures operating systems and hardware
• Updates the inventory of systems and assets of the company
• Troubleshoots basic networking functions (DHCP, DNS, TCP / IP)
• Performs system monitoring
• Troubleshoots hardware issues with regards to desktop and laptop computers and ensures that the issues have been repaired either in-house or under warranty
• Troubleshoots, resolves, and fixes network connectivity issues related to workstations
• Resolves network/telecommunications related issues with remote Users
• Performs basic troubleshooting and service of office and network printers
• Performs moves of computer systems and peripherals Education

Main Requirements and Skills

• DEC in Computer Science or related field
• 3 to 5 years of professional or academic experience in IT support
• Able to work in fast-paced regulated environment
• Required to work on site supporting end user
• Comply to the company’s COVID-19 policies
• Very good knowledge of the Windows environment
• Good understanding of the components of LAN and WAN networking
• Resourceful, with good troubleshooting and resolution skills
• Excellent customer service skills
• Excellent communication skills
• Bilingual (French and English)

Position Summary

CellCarta is seeking a Sample Management Technician to work closely with the Operations teams, receiving and managing samples as well as reagents and materials.

Main Responsibilities

• Perform the reception, inventory and storage of samples and study reagents
• Confirm proper shipment conditions and delivery or communicate any discrepancy or shipment non-conformity to designated individuals
• Manage the sample tracking between the storage area and the laboratory
• Prepare the shipments of samples and study reagents to send to clinical sites, sponsors or collaborators
• Perform reception of reagents and material as well as inventories
• Keep samples and study reagents storage database (e.g. LIMS) updated
• Manage storage space for the various storage temperatures (from ambient to cryogenic)
• Maintain documentation relevant to the tasks at hand as per appropriate SOP and applicable GLP regulations and GCLP guidelines

Education

• DEC – with 1+ years of related experience

Main Requirements

• Strong attention to details and commitment to achieve good quality work
• Excellent time management and organizational skills to meet deadlines in a fast-paced, changing environment
• Effective interpersonal and communication skills
• Excellent record keeping
• Ability to work autonomously as well as part of a team
• Positive, professional attitude and ability to take initiative
• Knowledge and understanding of French and English, oral and written, sufficient to carry out procedures and protocols
• Proficiency with MS Office suite, specifically Excel
• Work schedule: Tuesday to Friday 10:30am to 6:30pm, Saturday 9:00am to 5:00pm

Résumé du poste

CellCarta est à la recherche d'un(e) technicien(ne) en gestion des échantillons pour travailler en étroite collaboration avec les équipes des Opérations, à recevoir et gérer les échantillons ainsi que les réactifs et la marchandise.

 Principales responsabilités

• Effectuer la réception, l'inventaire et l’entreposage des échantillons et des réactifs d'étude
• Confirmer les conditions appropriées d'expédition et de livraison ou communiquer toute discordance ou non-conformité d'expédition aux personnes désignées
• Gérer le suivi des échantillons entre l’aire d’entreposage et le laboratoire
• Préparer les envois d'échantillons et de réactifs d'étude à envoyer aux sites cliniques, sponsors ou collaborateurs
• Effectuer la réception des réactifs et du matériel ainsi que les inventaires
• Tenir à jour la base de données d’entreposage des échantillons et des réactifs d'étude (ex. LIMS)
• Gérer l'espace d’entreposage pour les différentes températures d’entreposage (d'ambiant à cryogénique)
• Tenir à jour la documentation relative aux tâches à accomplir conformément aux MON appropriées et aux réglementations BPL applicables et aux directives BPLC

Formation

• Diplôme collegial – avec 1+ ans d’expérience pertinente

Exigences principales

• Une grande attention aux détails et un engagement à réaliser un travail de bonne qualité
• Excellentes compétences en gestion du temps et sens de l’organisation afin de respecter les délais dans un environnement en constante évolution
• Solides habilités interpersonnelles et de communication
• Excellente tenue de la documentation
• Capacité à travailler de manière autonome et en équipe
• Attitude positive et professionnelle et capacité à prendre des initiatives
• Connaissance et compréhension du français et de l'anglais, oral et écrit, suffisantes pour exécuter les procédures et protocoles
• Maîtrise de la suite MS Office, en particulier d’Excel
• Horaire de travail: du mardi au vendredi de 10h30 à 18h30, le samedi de 9h00 à 17h00

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting an Assay development Manager

Department: Molecular Services

Based in

Wirlijk, Antwerp (Belgium)

Major responsibilities

The Assay Development (AD) Manager will:

• Manage, create and execute complex technical and laboratory aspects of assay development, verification and validation projects

• Design laboratory experiments, evaluate and review test data

• Implement quality requirements and prepares associated documentation

• Ensure timeliness, quality of results and efficient use of resources

• Identify and troubleshoot problems that may adversely affect test performance

• Document all activities and write operating procedures, such as test codes, work instructions and validation reports

• Work in conjunction with internal departments and serve as consultant to provide scientific expertise on project execution and design

• Develop and present data to internal and external stakeholders

• Prepare and lead departmental and client meetings

Profiel

• The AD manager preferably has a PhD degree in life sciences or a master’s degree in life sciences with minimum 5 years of relevant professional experience in a strongly regulated setting

• Thorough knowledge of molecular genetic technologies and technical/scientific field

• Demonstrate knowledge and understanding of, and ability to apply principles, concepts, practices and standards of assay development and analytical methods validation and sample testing

• Show meticulous attention to detail, proficient reasoning and problem-solving skills in experimental design, data analysis and data interpretation

• Great communication and organizational skills

• Result oriented, creative and analytical thinker with a problem-solving mindset

• Scientific integrity and eager to learn/assimilate novel concepts

• Excellent documentation skills

• Dynamic personality, a true team player with good interpersonal skills

• Able to work under pressure

▪ Language skills : Advanced knowledge, orally and in writing of English,
knowledge of Dutch and French is a plus
▪ PC skills : in depth knowledge of MS Office, LIMS system(s),
relevant software tools for data analysis, equipment operations, etc.

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth

• A company that is fit for the future

• A competitive salary and benefits

• A great team you can work with

Position Summary

Reporting to the Group Leader, the incumbent will work within a team dedicated to the characterization of cellular ( various flow cytometry assays such as PBMC phenotyping, and the detection of intracellular cytokines, etc.) and humoral (ELISA tests, Luminex, viral neutralization tests, etc.) response.

Main responsibilities:

• Perform tests according to current procedures;
• Manage reagent orders and inventory required to perform assays;
• Participate in the joint technical management of the laboratory;
• Respect laboratory’s current standards, apply quality system procedures and participate in the implementation and improvement of quality documents.

Required skills and experience

• Bachelor's degree in biology, medical biology or equivalent;
• 1 to 3 years of laboratory experience;
• Solid theoretical and practical knowledge of immunology related techniques is required;
• Experience with the execution of flow cytometry assays assays a must;
• Experience with the execution of ELISpot and ELISA assays a must;
• Experience in cell culture and manipulation of infectious material in BL2 + environment is an asset;
• Strong organizational skills;
• Be motivated to actively participate in the implementation and continuous improvement of the laboratory process;
• Ability to work within a normative framework (GLP) and apply sound document management practices (SOP);
• Knowledge of written English is a must and French communication skills an asset.

Work conditions

Rotating schedules between evening and weekend shifts:

-Evening: Monday to Friday, from 1:00 pm to 9:00 pm

-Weekend: Wednesday to Friday, from 1:00 pm to 9:00 pm AND Saturday to Sunday, from 9:00 am to 5:00 pm

Sommaire du poste

Se rapportant au gestionnaire de laboratoire, le titulaire du poste travaillera au sein d’une équipe dédiée à la caractérisation de la réponse immunitaire cellulaire (ELISPOT et essais de cytométrie en flux variés tels que phenotypage de PBMC, et la détection de cytokines intracellulaires, etc) et humorale (tests ELISA, Luminex, tests de neutralisation virale, etc.).

Horaire: Mercredi au Vendredi de 13h à 21h et le samedi et dimanche de 9 à 17h

Principales responsabilités

• Réaliser les essais selon les procédures en vigueur;
• Gérer l’inventaire et les commandes des réactifs nécessaires à l’accomplissement des essais;
• Participer à la gestion technique commune du laboratoire;
• Respecter les normes en vigueur dans le laboratoire, appliquer les procédures du système qualité et participer à la mise en place et à l’amélioration de documents qualité.

Compétences et expérience requises

• Baccalauréat en biologie, biologie médicale ou biochimie (option biotechnologie) ou équivalent;
• 1 à 3 ans d’expérience en laboratoire;
• Minimum un an d'expérience en cytométrie en flux;
• Une bonne connaissance théorique et pratique des techniques liées à l’immunologie est requise;
• L’expérience en culture cellulaire et en manipulation de matériel infectieux en environnement BL2+ est souhaitée;
• Démontrer de très bonnes aptitudes organisationnelles;
• Être motivé à participer activement à l’établissement, la mise en place et l’amélioration continue de processus au laboratoire;
• Être apte à travailler dans un cadre normatif (GLP) et à appliquer les bonnes pratiques de gestion documentaire (SOP);
• Avoir une connaissance fonctionnelle de l’anglais écrit.  La connaissance de l’anglais parlé est un atout.

Sommaire du poste

CellCarta est à la recherche d’un scientifique très motivé et enthousiaste possédant une solide formation et une expérience pratique dans le domaine des immunoessais (MSD et ELISA). Le candidat ou la candidate jouera un rôle essentiel dans l'analyse d'échantillons d’une variété de fluides biologiques et d'échantillons d'étude de tissus en suivant les procédures normalisées d’exploitation (PNE) et les bonnes pratiques de laboratoire (BPL). Il ou elle devra également procéder à l'optimisation/qualification et à la validation des méthodes.

Responsabilités principales

• Analyser les échantillons biologiques par spectrométrie de masse
• Analyser des échantillons biologiques par immunoessais (ELISA et MSD)
• Développer et valider les essais immunologiques (ELISA et MSD)
• Concevoir et réaliser de manière autonome des expériences de dépannage
• Appliquer l'expertise technique pour modifier et améliorer le flux de préparation des échantillons
• Exécuter le travail selon les procédures établies
• Conserver la documentation relative à l'étude conformément aux BPL et aux orientations réglementaires
• Contrôler le rendement des équipements et enregistrer les activités dans les registres
• Effectuer des tâches générales de laboratoire
• Préparer et examiner la documentation relative aux expériences
• Effectuer des travaux dans un environnement BPL et, occasionnellement, dans un environnement de confinement de niveau 2 (CL2)

Compétences et expérience requises

• B.Sc. ou M.Sc. en sciences de la vie, chimie ou biochimie (ou équivalent)
• Un minimum de 2 ans d'expérience pertinente
• Connaissance et expérience  indispensables dans la réalisation de tests ELISA et MSD
• Connaissance du traitement des échantillons pour l'analyse protéomique, comme les techniques d'immunodépression et de digestion, un atout
• Expérience pratique dans la qualification ou dans la validation des méthodes en conformité avec les exigences réglementaires fortement souhaitée
• Connaissance et compréhension de la réglementation en matière de BPL
• Excellentes compétences en matière de gestion du temps et d'organisation pour respecter les délais dans un environnement en constante évolution
• Capacité à travailler de manière indépendante, autonome et dans une équipe
• Aptitude à tester avec précision un grand nombre d'échantillons avec une répétabilité fiable
• Bonne tenue de dossiers, attention aux détails et engagement à réaliser un travail de qualité
• Esprit critique et habilités de dépannage fortement souhaités
• Expérience de travail dans l'industrie

________________________________________________________

Summary

CellCarta is seeking a highly motivated and enthusiastic Scientist with strong background and hands-on experience n immunoassays (MSD and ELISA). This individual will play a key role in analyzing samples on a variety of biological fluids and tissue study samples following Standard Operating Procedures (SOP) and Good Laboratory Practices (GLP). He will also be required to perform method optimization/qualification and validation.

Main Responsibilities

• Process biological samples for analysis by Immunoassay (ELISA and MSD)
• Develop, and validate Immunoassay (ELISA and MSD)
• Autonomously design and perform experiments for troubleshooting
• Apply technical expertise to modify and improve sample preparation workflow
• Execute work as per established procedures
• Maintain study-related documentation according to GLP and regulatory guidance
• Monitor the performance of equipment and recording activities in logbooks
• Perform general laboratory duties
• Prepare and review documentation for experiments
• Perform work in a GLP environment and occasionally in a containment level 2 (CL2) environment

Experience and skills required

• B.Sc. or M.Sc. in life sciences, chemistry or biochemistry (or equivalent)
• A minimum of 2 years of relevant experience;
• Knowledge and experience with ELISA and MSD assays is a must
• Knowledge of sample processing for proteomics analysis, such as immuno-depletion and digestion techniques is an asset
• Hands on method Qualification/Validation experience in compliance with regulatory requirements is highly desired.
• Knowledge and understanding of GLP regulations;
• Excellent time management and organizational skills to meet deadlines in a fast-paced, changing environment;
• Ability to work independently, autonomously and as part of a team;
• Skill to accurately test large numbers of samples with reliable repeatability;
• Good record keeping, attention to details and commitment to achieve good quality work;
• Critical thinking, troubleshooting is highly desired
• Experience working in industry.

We are a leading global CRO laboratory with headquarters in Canada. Our mission is to map precision medicine by providing comprehensive testing solutions and biomarker research to the top global pharmaceuticals and biotech companies.  We are committed to providing superior science through proactive partnerships with our clients.

A scientific team that upholds the highest quality standards

More than your traditional CRO, we have a scientist-to-scientist approach and our culture is one of flexibility, accessibility, and service excellence. We are looking for science enthusiasts driven by innovation and eager to join a diversified team of scientists.

At CellCarta we are committed to giving our team the very best. Join us as we continue to expand internationally and be part of the future of precision medicine.

Purpose of the role

The Scientific Business Director represents the scientific interface between the client and our organization globally. Specifically, the Scientific Business Director shall be a:

Scientific Response to Business Development Support Needs

• Provide specialized scientific subject expertise to secure project wins
• Participate in planning key account strategies
• Prioritize and execute on strategic opportunities, leveraging the SBM’s knowledge and network

High Value Target (HVT) Embedded Partner

• Using deep platform knowledge, SBD will nurture and embed themselves within a defined HVT
• Leverage the Company’s relationships and reputation with key decision makers to enhance the credibility of its products and brand.

• Gain the trust and dependence of the HVT decision makers
• Engage HGX CBO and other senior management team members to transition client from transaction to enterprise partnership

Industry Scientific Ambassador

• Provide scientific presentations or posters to catalyze client interest and inquiries
• Author scientific white papers or peer-reviewed publications

Technology Maven

• Establish and maintain peer relationships with academic cores according to platform. Package and integrate expert-level user information for pharma clients to establish credibility
• Maintain learning relationships with technology vendors with specific intentions for co-promotion and marketing
• Identify emerging platforms of interest via the KOL-client iterations
• Validate R&D concepts with client and KOL base

Internal Evangelist

• Sow idea/concept seeds within the organization. Nurture those that need to take root by providing awareness and informational training
• Provide and describe relevant business case support to enable research and product development

Responibilities

• Drive new business for SBD’s segment interest - scientific lead generation, client interaction  and technical presentations.
• Review and provide content for RFP development and defense
• Organize and share client organization information using available tools (salesforce.com or AirTable)
• Provide platform-of-expertise training to business development teams
• Assist in developing monthly, annual, and multi-year sales forecasts and measure results against them
• Establish a client peer network of platform experts. Maintain and nurture the network so they can be called upon for Company initiatives
• Summarize and socialize strategic client needs within the organization via scheduled events
• Provide support to enable pricing, contractual or negotiation decisions
• Ensure the appropriate level to level introductions between clients and Company
• Liaise with marketing team to provide content
• Credibly and effectively communicate with the internal scientific team to help develop “solutions” that address unique client needs. 

Qualification and Skills

The Scientific Business Director will need to demonstrate the following critical competencies:

• Analytical Capability.  The ability to develop relevant analytical models to define complex value propositions to senior level client representatives – scientists and business executives.  Proven ability to manage rapid-fire analysis across a broad front of issues and businesses
   
• Communication Savvy.  Have an impeccable sales presence and be comfortable with clients globally, as well as comfortable through all levels of an organization.  He/she will have a strong industry reputation and be able to represent the Company as a credible and respected speaker at industry events/panels
   
• Relationship Building.   The successful Candidate will be able to establish business relationships with high level, decision-making counterparts within potential business development partners.  He/she will be convincing and constructive, both in representing the Company, and the rationale of the specific initiatives

Description du poste

CellCarta est à la recherche d’un(e) infirmier/infirmière auxiliaire de recherche pour mener à bien les prélèvements sanguins dans le cadre d’un projet de recherche sur des individus sains.

Principales Responsabilités

• Organiser le calendrier des prélèvements en fonction des besoins du laboratoire;
• Prendre rendez-vous avec les participants volontaires pour les prélèvements;
• Donner toutes les explications requises et répondre à toutes les questions afin d’obtenir un consentement éclairé des participants;
• Vérifier l’identité et valider l’éligibilité des participants en fonction des critères du protocole de recherche;
• Procéder aux prélèvements sanguins en respectant le protocole de recherche et les règles éthique;
• S’assurer du bien être des participants avant, pendant et après le prélèvement sanguin;
• Gérer la base de données des participants de l’étude;
• Gérer le matériel de prélèvement sanguin et transmettre les besoins d'approvisionnement à l’équipe en charge;
• Toutes autres tâches en support au groupe de gestion des échantillons.

Éducation et Expérience Recherchées

• Diplôme de formation professionnelle en Soins Infirmiers ;
• 1 an d’expérience en tant qu'infirmière auxiliaire;
• Membre de l’OIIAQ ou autre accréditation pertinente.

Compétences Exigées

• Attention au détail et engagement à offrir un travail de qualité;
• Excellente gestion du temps et bonne capacité à gérer les priorités pour respecter les échéanciers dans un environnement dynamique et en évolution constante;
• Très bonnes aptitudes de communication et d’interactions avec les gens;
• Bonne tenue des dossiers;
• Rigueur dans la collecte de données;
• Souci de la confidentialité;
• Capacité de travailler de façon autonome;
• Attitude positive et professionnelle;
• Capacité à prendre des initiatives et résoudre des problèmes;
• Bilingue – Français et Anglais;

________________________________________________________

Job Description

CellCarta is currently seeking a Research Nursing Assistant to carry out blood tests as part of a research project on healthy individuals.

Principal responsibilities

• Organize the sample schedule according to the needs of the laboratory;
• Make appointments with voluntary participants to obtain samples
• Provide all required explanations and respond to all questions to obtain informed consent from participants
• Verify the identity and eligibility of all participants in conjunction with the criteria of the research protocol
• Conduct all blood tests while respecting research protocols and code of ethics
• Ensure the well-being of all participants at the start, during, and after blood tests
• Manage the participant database per study
• Manage the materials for blood tests and communicate all orders to the procurement team
• Other tasks may include providing support to the sample management group

Education and Experience

• Professional Diploma in Nursing
• A minimum of 1 year in a similar role
• Member of the Ordre des infirmières et infirmiers auxiliaires du Québec (OIIAQ) or other relevant accreditation

Required Skills

• Attention to detail and commitment to offering quality work
• Excellent time management skills and organizational skills to meet deadlines
• Very good communication and interpersonal skills
• Good at keeping records
• Rigorous when collecting data
• Confidentiality
• Ability to work autonomously
• Positive and professional attitude
• Takes initiative and can successfully solve problems
• Bilingual - French and English

Key Responsibilities

• Lead Method Validation and Sample Analysis studies based on approved driving documents;
• Works in collaboration with the Principal Scientists, Lead Scientists, Research Assistants in the lead of studies to deliver quality data on time;
• Plan required experiments based on the timelines, priorities and requirements, working in collaboration with Schedulers/Group Leaders/Managers;
• Writes and reviews SOP/CSP;
• Ensure staff have read driving documents and are trained on method prior to performing the work;
• Prepares and/or reviews experimental documentation for assigned studies;
• Prepares and/or complete associated documentation relevant to the studies as per applicable procedures;
• Attend study initiation meetings for their assigned studies;
• Ensure Lead Scientists have sufficient (and qualified) reagents to perform the work;
• Follow up on deviations and note to file (ensure they are observed, initiated, impact evaluated and closed in a timely manner);
• Initiate and maintain the study binder throughout the study;
• Ensure expected study samples have been received, logged, analyzed, destroyed (if applicable) or returned (if applicable);
• Follow-up on sample manifest and ensure sample discrepancies are resolved;
• Understands all activities required for proper execution of lab work ;
• Ensures required study documents are completed, reviewed, approved;
• Prepare binders for QA submission, submit studies to QA and answer QA reports;
• Assists group leaders and/or managers in their responsibilities;
• Ensure SOPs and CSPs are compliant and technically sound;
• Ensure any assigned staff are qualified for their studies and execute the work properly;
• Responsible for coaching, mentoring, training and day to day interaction with the Lead Scientists and Research Assistants;
• Provides recommendations for quality improvements as well at a technical level for excellent laboratory execution;
• Provide strong leadership to foster communication and promote team building.

Education

• Bachelor’s degree in Biosciences or related field

Required Experience and Skills

• Knowledge of the GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) regulations.
• 1 to 2 years of work experience in the biopharmaceutical industry
• Minimum of 3-5 years of equivalent experience
• Scientific knowledge in biochemistry and immunology
• Capacity to multitask and work on multiple projects in parallel under strict time constraints and perform under pressure
• Excellent organizational skills and ability to prioritize
• High degree of initiative, sense of urgency and flexibility
• Experience coaching and training employees
• Ability to work independently as well as in a team environment
• Strong track record delivering projects on schedule and scope
• Excellent problem-solving skills
• Meticulous with great attention to detail
• Bilingual – Verbal and written in French and English
• Knowledge of Microsoft Office programs, specifically Word and Excel

Principales responsabilités

• S’assurer de la bonne exécution des projets de validation et analyses d’échantillons en accord avec les documents de références.
• Travailler en collaboration avec les scientifiques principaux, lead assistants de recherches, assistants de recherche dans le déroulement des études pour fournir des données de qualité dans les délais.
• Planifier les expériences requises en fonction des délais, des priorités et des exigences, en collaboration avec les planificateurs / chefs de groupe / gestionnaires.
• Écrire et réviser procédures (SOP/CSP).
• Préparer et/ou réviser la documentation expérimentale pour études assignes; Assister à des réunions de démarrage aux études pour les études qui lui sont assignées.
• Veiller à ce que les assistants de recherche séniors aient suffisamment de réactifs pour effectuer le travail.
• Assurer le suivi des déviations et rédiger des notes aux dossiers (note to file) (veiller à ce qu’ils soient observés, mis en œuvre, évalués et conclus rapidement).
• Créer et maintenir le cartable de l’étude tout au long de l’étude.
• S’assurer que tous les échantillons d’étude ont été reçus, consignés, analysés, détruits (le cas échéant) ou retournés (le cas échéant).
• Comprendre toutes les activités nécessaires à la bonne exécution des travaux de laboratoire.
• Préparer la documentation pour soumission au département d’assurance qualité.
• Répondre aux rapports d’assurance qualité.
• Aider les chefs de groupe et/ou les gestionnaires à s’acquitter de leurs responsabilités.
• Veillez à ce que les POS et les CSP soient conformes et techniquement viables.
• S’assurer que tout le personnel affecté effectue le travail correctement.
• Fournir des recommandations pour améliorer la qualité, notamment au niveau technique, en vue d’assurer l’excellence opérationnelle du laboratoire.
• S’assurer que le personnel a lu les principaux documents et suivi une formation sur la méthode à utiliser avant d’effectuer le travail.
• Faire preuve de leadership afin de favoriser la communication et de promouvoir le travail d’équipe.
• Responsable du coaching, du mentorat, de la formation et de l’interaction quotidienne avec les assistants à la recherche.

Éducation

• Baccalauréat en sciences biologiques ou un domaine connexe

Expérience et compétences requises

• Connaissance des BPL (bonnes pratiques de laboratoire) et des BPC (bonnes pratiques cliniques)
• 1 à 2 ans d’expérience professionnelle dans l’industrie biopharmaceutique
• Minimum de 3 à 5 ans d’expérience équivalente
• Connaissances scientifiques en biochimie et en immunologie
• Capacité à travailler sous pression, à effectuer plusieurs tâches en même temps et à travailler sur plusieurs projets en parallèle dans des délais très courts
• Excellentes sens de l’organisation et capacité à établir des priorités
• Grand sens de l’initiative, rapidité et flexibilité
• Expérience en matière de coaching et de formation des employés
• Capacité à travailler de manière autonome et en équipe
• Antécédents solides quant à la livraison de projets dans les délais prévus et conformément à la portée
• Excellentes compétences en résolution de problèmes
• Personne méticuleuse, avec un grand souci du détail
• Bilingue - français et anglais (oral et écrit)
• Connaissance des programmes Microsoft Office, particulièrement Word et Excel

Summary

The Research Assistant performs complex immune monitoring assays for clinical samples. Participates in writing of procedures (SOP/CSP). Trains other laboratory personnel on technical procedures/methods. Records associated documentation relevant to the tasks at hand as per appropriate SOP and applicable GLP regulations and GCLP guidelines.

Responsibilities

• Conduct complex experiments (blood processing, cell cryopreservation, ELISA, multi-parametric flow cytometry assays);
• Prepares and reviews documents for laboratory assay work including assay forms and/or worksheets
• Assists in the planning of experiments and helps in various activities (scheduling, preparation of reagents, documentation, etc) pertaining to the optimal operation of a clinical laboratory
• Trains other laboratory members on complex immunoassay methods for flow cytometry
• Write Equipment and Method SOP/CSP as required;
• Maintains all records and documents relevant to the tasks performed in the laboratory in compliance with GLP/GCP regulations and GCLP guidelines.

Education

• Bachelor's/Master's degree in Life Sciences, preferably in immunology, or Cell/Molecular Biology.

Experience and Skills

• Minimum of 1-3 years' experience in a similar position is preferred.
• Experience and knowledge in human blood sample processing and cell cryopreservation techniques, cell culture methods, cellular staining procedures using flow cytometry;
• Knowledge and understanding of working in a GLP/GCP compliant regulatory laboratory to conduct experimental procedures per defined technical SOPs, with experience of handling biohazardous materials, and understand safety procedures and guidelines.
• Ability to handle a relatively high volume of clinical sample processing and analysis, using immunoassay techniques.
• Good organizational and documentation skills.

Résumé de la position:

Le chef de groupe de laboratoire de CellCarta est responsable de la gestion quotidienne des assistants de recherche de laboratoire. Dans ce rôle, il / elle est responsable de la planification des travaux de laboratoire pour toutes les études en cours. Le chef du groupe de laboratoire s'assure que le personnel est correctement formé et compétent avec toutes les techniques utilisées et assure le suivi des performances du personnel. Le chef de groupe de laboratoire surveille également la qualité du travail et de la documentation du laboratoire pour garantir la conformité aux exigences applicables.

Responsabilités:

• Effectuer la gestion quotidienne du personnel pour l'équipe assignée;
• Planifie et coordonne les travaux de laboratoire pour tous les projets en cours et à venir, établissant les priorités et résolvant les conflits d'horaire avec d'autres chefs de groupe / équipe;
• Travaille avec d'autres chefs d'équipe pour s'assurer que le personnel est correctement affecté;
• Fournit des compétences techniques pour la conduite des méthodes (cytométrie en flux, ELISpot),
• Assurer l'intégrité technique / scientifique des tests effectués;
• S'assure par des inspections régulières que le personnel exécute le travail conformément aux BPL et Caprion SOP et CSP;
• Planifie et supervise la formation du personnel du laboratoire pour assurer la maîtrise des méthodes utilisées;
• S'assure que le personnel exécute le travail de manière efficace;
• Encadre le personnel sur la façon d'effectuer le travail de manière appropriée et efficace;
• Met en œuvre des actions correctives appropriées et efficaces dans le laboratoire pour minimiser les lacunes en BPL;
• Identifie les besoins en formation du personnel et les domaines de développement de carrière;
• Faire un suivi auprès du personnel affecté sur le rendement;
• Participe à des audits réalisés par des agences gouvernementales ou des clients;
• Effectue des activités liées à la biobanque (réception d'échantillons, suivi et inventaire) conformément aux procédures applicables;
• Effectue d'autres tâches assignées.

Conditions spéciales de la position:

• Doit accepter d'exécuter des tâches ou de superviser des activités dans des installations de niveau de sécurité biologique (BSL) 1 ou 2 où les échantillons biologiques peuvent être infectés naturellement ou expérimentalement par des virus potentiellement dangereux tels que le VIH, le VHC ou le CMV;
• L'employé est personnellement responsable du respect des directives / instructions en matière de santé et de sécurité.

Profil:

• B.Sc. ou M.Sc. en sciences de la vie ou équivalent, de préférence en immunologie.
• Au moins 3 ans en tant que chef d'équipe.

Connaissances requises:

• Expérience de travail avérée en tant que chef d'équipe.
• Connaissance pratique des opérations générales de laboratoire, en mettant l'accent sur les techniques d'analyse biologique;
• Bonne connaissance des techniques suivantes: traitement des échantillons sanguins, comptage cellulaire et techniques de cryoconservation des cellules, techniques de culture cellulaire, procédures d'immunocoloration, techniques de surveillance immunitaire, y compris la cytométrie en flux et ELISpot;
• Excellente connaissance des systèmes qualité, tels que GCP, GCLP, ISO / CEI 17025, 15189 et CAP;
• Connaissance des procédures et des protocoles de confinement des matières biologiques dangereuses, des procédures de sécurité et des directives.

Compétences requises:

• Excellentes compétences en leadership;
• Excellentes compétences en organisation et en gestion du temps pour respecter les délais dans un environnement en évolution rapide;
• Flexible pour guider l'équipe pendant et en dehors des heures d'ouverture:
• Capacité à prendre des décisions appropriées, en particulier dans des délais courts et dans des situations complexes;
• Capacité à effectuer plusieurs tâches à la fois.
• Capable de prioriser son travail ainsi que celui des autres;
• Excellente communication (français et anglais).
• Esprit de qualité solide.

Le masculin est utilisé par facilité.

Position Summary:

The Laboratory Group Leader at CellCarta is accountable for daily management of laboratory Research Assistants. In this role, he/she is responsible for scheduling laboratory work for all ongoing studies.  The Laboratory Group Leader ensures that staff is appropriately trained and proficient with all techniques used and follows up on staff performance.  The Laboratory Group Leader also monitors the quality of laboratory work and documentation to ensure compliance with applicable requirements.

Responsabilities:

• Performs the day to day staff management for assigned team;
• Schedules and coordinates laboratory work for all ongoing and upcoming projects, establishing priorities and resolving scheduling conflicts along with other group/team leaders;
• Works with other team leaders to ensure staff is properly allocated;
• Provides technical skills for the conduct of methods (flow cytometry, ELISpot),
• Ensure technical/scientific integrity of assays conducted;
• Ensures by regular inspections that the staff executes the work according to GLP and Caprion SOP and CSP;
• Plans and oversees training of the laboratory staff to ensure proficiency in the methods used;
• Ensures that the staff performs the work in an efficient manner;
• Coaches staff on how to perform work appropriately and efficiently;
• Implements appropriate and effective corrective actions in the laboratory to minimize GLP deficiencies;
• Identifies staff training requirement and areas for career development;
• Follows-up with assigned staff on performance;
• Participates in audits performed by government agencies or clients;
• Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures;
• Performs other duties as assigned.

Special Conditions of the Current Position:

• Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
• Employee is personally responsible for following Health and Safety guidelines/instructions.
• This position can involve evening and/or week-end work.

Profile:

• B.Sc. or M.Sc. in Life Sciences or equivalent, preferably in Immunology
• At least 3 years as team manager.

Knowledge Requirements:

• Proven work experience as a team leader.
• Practical knowledge of general laboratory operations, with focus on biological analysis techniques;
• Good knowledge of the following techniques: blood sample processing, cell counting, and cell cryopreservation techniques, cell culture techniques, immunostaining procedures, immune monitoring techniques including flow cytometry and ELISpot;
• Excellent knowledge of Quality Systems, such as GCP, GCLP, ISO/IEC 17025, 15189 and CAP;
• Knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines.

Skill Requirements

• Excellent leadership skills;
• Excellent organization and time management skills to meet deadlines in a fast-paced, changing environment;
• Flexible to guide team within and outside business hours:
• Ability to make appropriate decisions, especially under short timelines and when dealing with complex situations;
• Ability to multitask.
• Able to prioritize his/her work as well as the work of others;
• Excellent communication (French and English).
• Strong quality mindset.

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting an Imaging Scientist

Department: Pathology, Imaging and Quantification

Report to: Yannick Waumans

Based in

Wilrijk, Antwerp (Belgium)

Major responsibilities

• Analyses of whole-slide images of HE-, IHC- or IF-stained histological sections
• Enumeration and interpretation of (F)ISH-stained histological sections
• Collaborate with pathologists, other scientists and project managers to accurately
and timely deliver the data from these analyses
• Design imaging experiments to support the development of new IHC or IF assays
• Support the development, validation and documentation of new image analysis
algorithms for these assays
• Assist in writing standard operating procedures and keeping these up-to-date
• Communicate with internal and external stakeholders to elucidate analysis strategies
and interpretation

Background

• Master’s degree in Science (Veterinary Sciences, Biomedical Sciences,
Bio-engineering, Pharmaceutical Sciences, Biochemistry and Biotechnology)
• Solid basis in histology and/or microscopy skills
• Experience with image analysis software (Visiopharm, HALO, …)
and digital imaging is a plus
• Strong computer skills and significant experience with Microsoft Excel,
Powerpoint and Word
• Background in databases and statistical analysis (SQL, R, python, …) is a bonus
• You have excellent communication skills, you are diplomatic and a team player
with a positive attitude
• Fluent in English both written as well as spoken
• Detail-oriented person
• Ability to work in a fast-paced environment
• Ability to maintain methodic and high precision in routine practice

What can we offer

Go Further
• Exciting and superior scientific environment with a multidisciplinary team of experts
• Multiple growth opportunities

Move with Confidence
• The assurance that comes from working for an established leader
• The reputation of a scientific team that upholds the highest quality standards

Make a difference
• The opportunity to significantly contribute to the next generation of life-changing
drugs in precision medicine
• Join a global CRO where your expertise matters and contributions can be felt

Our Values

• Collaboration
• Customer Excellence
• Respect
• Trust & Accountability

Summary

CellCarta is seeking a highly-motivated and enthusiastic Scientist for its proteomic sample processing team. This individual will play a key role in performing a variety of techniques such as immuno-depletion, digestion and analysis by SCX and HPRP Chromatography on a variety of biological fluids and tissue study samples following Standard Operating Procedures (SOP) and Good Laboratory Practices (GLP).

Main Responsabilities

• Process biological samples for analysis by mass spectrometry
• Autonomously design and perform experiments for troubleshooting
• Apply technical expertise to modify and improve sample preparation workflow
• Execute work as per established procedures or R&D work instructions
• Maintain study-related documentation according to GLP and regulatory guidance
• Monitor the performance of equipment and recording activities in logbooks
• Perform general laboratory duties
• Prepare and review documentation for experiments
• Perform work in a GLP environment and occasionally in a containment level 2 (CL2) environment

Main Requirements

• B.Sc. or M.Sc. in life sciences, chemistry or biochemistry (or equivalent)
• A minimum of 3 years of relevant experience;
• Knowledge of sample processing for proteomics analysis, such as immuno-depletion and digestion techniques
• Knowledge and experience with chromatography-based techniques (eg., operating HPLC instruments)
• Knowledge and understanding of GLP regulations;
• Excellent time management and organizational skills to meet deadlines in a fast-paced, changing environment;
• Ability to work independently, autonomously and as part of a team;
• Skill to accurately test large numbers of samples with reliable repeatability;
• Good record keeping, attention to details and commitment to achieve good quality work;
• Experience working in industry.

Sommaire

Le titulaire du poste jouera un rôle clé en exécutant une variété de techniques telles que l’immuno-déplétion, la digestion et l'analyse par SCX et par chromatographie HPRP sur une variété de liquides biologiques et des échantillons de tissus suivant des procédures opérationnelles standardisées (POS) ainsi que les bonnes pratiques de laboratoire (BPL).

Responsabilités principales

• Préparer des échantillons biologiques pour l’analyse par spectrométrie de masse;
• Effectuer le travail en suivant des POS ainsi que d’autres procédures de R& D;
• Participer à la résolution de problèmes;
• Documenter le travail effectué selon les BPL et autres normes en vigueur;
• Monitorer la performance des instruments utilisés et consigner les informations dans les registres appropriés;
• Effectuer des tâches de laboratoire générales;
• Préparer et vérifier des procédures de R&D;
• Effectuer le travail dans un environnement BPL et occasionnellement en niveau de confinement 2.

Compétences et expériences requises

• B.Sc. ou M.Sc. en sciences de la vie, chimie ou biochimie (ou champ connexe).
• Minimum de 3 ans d’expérience pertinente;
• Connaissance et expérience de techniques de préparation d’échantillons telles que l’immuno-déplétion, la digestion et l’extraction sur phase solide
• Connaissance et expérience avec des techniques de chromatographie (e.g. utilisation d’instruments de HPLC)
• Connaissance et compréhension des normes BPL en vigueur;
• Excellente gestion de temps et organisation afin de rencontrer les échéanciers dans un environnement très dynamique;
• Capacité à travailler de façon autonome et en équipe;
•  Capacité à préparer de grands nombres d’échantillons de manière reproductible;
• Bonnes pratiques de documentation, souci du détail, minutie et engagement à effectuer un travail de qualité;
•  Expérience de travail dans l’industrie .

Position Summary:

The Group Leader, Clinical Sample Analysis Team reports to the Director of Operations.

His/her responsibilities are:

• Perform the day to day staff management for assigned team,
• Resolve scheduling conflicts along with other group/team leaders,
• Works with other team leaders to ensure staff is properly allocated,
• Provide technical skills for the conduct of methods (flow cytometry, ELISpot),
• Ensure technical/scientific integrity of assays conducted,
• Ensures that the staff executes the work according to GLP and Caprion SOP and CSP
• Ensures that the staff performs the work in an efficient manner
• Coaches staff on how to perform work appropriately and efficiently
• Implements appropriate and effective corrective actions in the laboratory to minimize GLP deficiencies
• Identifies staff training requirement and areas for career development.
• Follows-up with assigned staff on performance.

Education

B. Sc. or M.Sc. in biological sciences

Experience

At least 3 years as team manager

Required Expertise and Skills

• Proven work experience as a team leader;
• Good knowledge of ELISpot and flow cytometry techniques;
• Excellent communication (English and French) and leadership skills;
• Organized with excellent time-management skills;
• Flexible to guide team within and outside business hours;
• Able to prioritize his/her work as well as the work of others;
• Ability to multitask.

Sommaire

Relevant de la gestionnaire des opérations, le titulaire du poste est en charge de la supervision de son équipe, de l’intégrité scientifique et technique des essaies en cours et participe à l’amélioration continue des processus.

Principales Responsabilités

• Coordonne le travail de son équipe;
• Responsable de l’intégrité technique et scientifique des essaies fait par son équipe;
• Participe à l’élaboration de la cédule des projets en cours et parfois des projets à venir;
• Assiste à l’établissement des priorités et à la résolution des conflits de cédule;
• Prend part à l’amélioration continue dans son département;
• Mets en place les mesures correctives appropriées dans le laboratoire, afin de minimiser les déficiences réglementaires;
• Apporte un soutien technique dans les méthodes d’Immune-Monitoring;
• Collabore avec les autres chefs d’équipe, afin de s’assurer que les effectifs sont bien alloués;
• S’assure que les essais et le QC sont conduit efficacement et dans le respect des normes GLP et des SOP/CSP internes;
• Supervise les membres de son équipes et responsable de l’évaluation de la performance de son groupe et du développement professionnel de celui-ci;
• Responsable de la formation et du coaching des membres de son équipe.

Éducation

• Baccalauréat ou Maîtrise en Biologies

Compétences et Expériences requises

• Minimum 3 ans d’expérience en gestion d’équipe dans l’industrie pharmaceutique/CRO;
• Solides aptitudes de gestion;
• Solides aptitudes en leadership et en communication;
• Faire preuve d’organisation et bonne gestion du temps;
• Capacité à prioriser son travail et celui des autres;
• Capacité à gérer plusieurs tâches à la fois;
• Capacité à s’adapter au changement et à communiquer le changement;
• Faire preuve de flexibilité et de disponibilité;
• Bonnes connaissances des techniques de cytométrie en flux et Élisa;
• Bilingue français – anglais.

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We'd love to find a Clinical Study Associate to help us serve our sophisticated customers while adhering to our rigorous but sensible procedures.

As a CellCarta Clinical Study Associate (CSA) you are part of the Clinical Operations team. You perform query and planning management and support the study set-up activities. As a Clinical Study Associate you support the Project Manager on daily administrative tasks and for embodying 3T’s. Always keep the project on Task, on Track and on Time.

Based in

Wilrijk, Antwerp (Belgium)

Roles & Responsibilities

The CSA is responsible for the delivery of specific study tasks, generally overseen by the study Project Managers. The specific tasks are time sensitive and will be followed up accordingly.

The CSA ensures that the activities and tasks are accomplished within the CellCarta quality system.

Below is a non-limitative list of accountabilities.

1. Study set-up

• Preparation of applicable study documentation

• Complete the study set-up within a Laboratory Inventory Management System (StarLims)

2. Query management for short TAT (turnaround time) samples

• Preparation of new DCFs (Data Clarification Forms)

• Follow up of answered DCFs

3. Planning management

• Planning of tests after sample receipt

4. Active support of the Project Managers

5. Participate in process improvement initiatives

Purpose of the function

To support projects with internal stakeholders in order to deliver results on time in full and in agreement with the CellCarta Quality System. Clinical Study Associates have administrative skills, interest in databases and work closely with the Project Managers.

Required education

A Bachelor degree preferably in life sciences, nursing or a related field of study; Business Administration or similar expertise through experience.

Qualification and Skills

The CSA uses an arsenal of skills to successfully perform the required tasks.

On your first day, we'll expect you to have:

− 2+ years of administrative management, and/or CRA (clinical research associate), CTA experience, or a history of working with histo-technology laboratories

− Strong communication skills, proficient in English language, both written and oral communications; other languages desirable

− Proficient in Microsoft Office (Word, Excel, PowerPoint)

− Excellent organizational skills and able to multi-task

− Positive and energetic attitude

− Able to take initiative, be adaptable, and strive in a dynamic environment

− Diligence and strong attention to detail

− Ability to work independently and as a team member

− Possesses critical thinking and problem solving skills

− Customer and Project Manager service oriented

− Communicate effectively with various internal stakeholders in a positive and professional manner

It's great, but not required, if you have:

− Experience in cancer research

− Have a working knowledge of ICH-GCP guidelines related to clinical trials

− Worked in global locations

We offer an exciting and challenging full-time position in a multinational environment where customer focus and innovation are key business values. You will receive thorough on-the-job-training.

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting an Excel VBA Developer

Department: Bioinformatics

Based in

Wirlijk, Antwerp (Belgium)

Function

HistoGeneX is a growing global CRO specializing in the field of immune-oncology. We strive to make a difference in the future treatment options offered to cancer patients.

We are looking for an Excel VBA Developer who will focus on creating Excel VBA applications that increase workflow efficiency within the genomics unit, creating solutions to capture data to SQL databases and assist in the incorporation of the molecular tests in HistoGeneX StarLIMS system. This role will play a crucial part in the build out of our company’s genomics unit.

Major responsibilities

• Develop Excel VBA applications and forms that improve operational efficiency in the genomics unit
• Develop data solutions for collecting and importing data from different sources into
SQL databases and LIMS system
• You will have the opportunity to experiment with the data to gain both business and clinical insights
• Participate in the validation of these solutions

Profiel

• Bachelor or master in science (engineering, computer science, bio-informatics,…)
• Knowledge of and Experience in Excel VBA is a must
• Knowledge of SQL, Microsoft SQL server and/or LIMS systems is a differentiator
• Familiarity with principles and methods of software development and validation
as well as familiarity with (molecular) laboratory work is highly advantageous
• Good working knowledge of one or more of the following is advantageous:
API, Python, PHP, HTML, R & Shiny apps, ELN
• You are analytical, well organized, result orientated and a team player capable of working under
a minimum of supervision
• You combine strong technical skills with excellent communication skills
• Fluent in English both written and spoken

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth

• A company that is fit for the future

• A competitive salary and benefits

• A great team you can work with

Position Summary

Caprion is seeking a Program Manager to organize and coordinate scientific programs. The Program Manager provides strategic guidance to teams and Principal Scientists to align with the company’s objectives.

Main Responsibilities

• Provides support at the project-level activity to ensure the program goals are met by providing a decision-making capacity that cannot be achieved at project level;
• Provides the Principal Scientists with a program perspective when required, or as a sounding board for ideas and approaches to solving project issues that have program impacts;
• Monitors overall project objectives, milestones and timetables for achieving intermediate and overall project goals;
• Identifies and manages cross-project dependencies and provides support in prioritizing projects when needed;
• Sets review dates to ensure that projects remain on target;
• Proactively assesses program performance; Will coordinate and monitor progress across all projects and establish a formal reporting structure for overall program progress;
• Develops and monitors deadlines and budgets overall for program milestones;
• Helps resolve issues and initiates appropriate corrective actions (or interventions) wherever gaps in the program are identified;
• Performs tracking of deliverables in conjunction with client and internal customers;
• Supports ongoing teleconferences with the client, managing the agenda and meeting minutes;
• Provides timely notification to all appropriate parties with deviations from timelines and/or deliverables;
• Conducts regular communication with team members, formal and informal, regarding study status or any other changes;
• Performs capacity planning for upcoming programs (as well as projects).

Education

Scientific background (i.e. MSc in life science)

Main Requirements

• Minimum of 3 to 5 years of experience in a CRO or in biotechnology as a Project Manager;
• Excellent multitasking and tracking skills;
• Effective leadership, interpersonal and communication skills;
• Ability to find ways of solving or pre-empting problems;
• Knowledge of the immune monitoring field;
• Knowledge of industry standards for the conduct of analytical studies;
• Knowledge of regulatory requirements for the conduct of analytical studies in support of clinical trials (exploratory vs secondary/primary endpoints);
• Ability to create a sense of community amongst the members of the project teams;
• Excellent knowledge of project management and budgeting;
• Sufficient seniority and credibility to advise project teams on their projects in relation to the program;
• Proficiency with Excel;
• Fluent in English, French is an asset.

Sommaire du poste
Le/la technicien/ne de laboratoire fournit un soutien général au groupe de développement afin de préparer des réactifs, des échantillons et assurer la culture cellulaire nécessaire au développement de procédures. Elle/Il participe au maintien des équipements et de l’environnement de laboratoire, à l’inventaire du matériel et des échantillons. Le/la technicien/ne de laboratoire travaillera dans un environnement BPL en suivant des méthodes PON.

Principales responsabilités
• Apporte un support dans la préparation quotidienne des expériences tel que la préparation des échantillons et des réactifs;

• Prépare les échantillons selon différentes techniques: isolation cellulaire à partir d’échantillons sanguin, comptage, stimulation cellulaire, décongélation, cryopréservation;

• Responsable de la culture de lignées cellulaires;
• Prépare les solutions et les aliquots de réactifs;
• Fait la maintenance, la calibration et le nettoyage des équipements;
• S’assure de remplir les stocks lorsque vide et fait l’inventaire;
• Supporte les tâches de documentation expérimentale.

Formation requise
• DEC en Technique de laboratoire, avec orientation en sciences de la vie (ou similaire), B.Sc. en sciences de la vie.

Compétences et expérience requises
• Idéalement, >1 an d’expérience en laboratoire;
• Expérience de travail avec une hotte de biosécurité dans des conditions stériles;
• Expérience de travail avec les PBMC (isolement par Ficoll, cryoconservation, décongélation, comptage avec hémocytomètre);

• Expérience de culture cellulaire (lignées cellulaires);
• Expérience dans un environnement BPL/GCLP, un atout;
• Être organisé et rigoureux dans son travail;
• Capacité à bien documenter son travail et souci du détail;
• Dynamique, et motivé/e, résolution de problème, esprit d’équipe, aptitude/intérêt à travailler avec de l’instrumentation de précision, flexibilité dans un environnement rapide et adaptatif;

• Fonctionnel en anglais.

Notes Particulières
• Travail en niveau de biosécurité 1 et 2, avec des échantillons biologiques qui peuvent être naturellement ou expérimentalement infectés avec des virus cotés biosécurité tels que HIV, HCV et CMV.

Summary
The research assistant leads and performs development experiments using multiple technologies (flow cytometry, immunoassays, ELISpot, cell culture…). To this purpose, the research assistant prepares the experimental documentation, the reagents, samples and performs the experiment. The role also involves the maintenance of the project’s documentation to comply to GLP and the writing of the SOP for the develop methods.

Main Responsibilities
• Performs laboratory-based experimentations involving cell culture, flow cytometry, immunoassays (ELISA, MSD) and ELISpot;

• Works with various human samples: whole blood, PBMC, bone marrow aspirates…;

• Prepare all required reagents and samples for the experimentations to be performed;

• Prepare and maintain the experimental and project documentation (GLP);

• Write the SOP related to the developped method;

• Perform the assay development in the described timelines;

Education
• B.Sc. or M.Sc in life sciences

Main Requirements
• 5 year experience in laboratory work in the industry;

• Experience and expertise with flow cytometers (>6 colors), in settings experiments and troubleshooting;
• Experience in working with a biological safety cabinet using sterile conditions;
• Experience in working with PBMC (isolation by Ficoll, cryopreservation, thawing, counting with hemocytometer);

• Experience in cell culture (cell lines);
• Experience in a GLP/GCLP environment an asset;
• Organized and rigorous in the conduct of their work;
• Good record keeping skills and attention to detail;
• Troubleshooting skills

• Dynamic, motivated, analytical thinking, communication skills, flexibility and adaptability

Special Conditions

• Must accept to perform duties activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV.

• Occasionally, work schedule may be adapted to accommodate operational needs.

Summary
The laboratory technician provides a general support to the development team in preparing the reagents, samples and performing the cell culture required for assay development. The technician participates in the maintenance and upkeep of equipment/ laboratory environment and to the inventory of reagents and samples. He may also provide support to the development team members in the execution of some experiments.The laboratory technician is working in a GLP environment, following SOP.

Main Responsibilities
• Provides support in daily experiment preparation such as preparing samples and reagents;

• Performs sample preparation such as cell isolation from blood sample, cryopreservation, thawing, counting;

• Responsible for cell lines culture;
• Prepares solutions and reagent aliquots;
• Performs equipment maintenance, calibration, and cleaning;
• Replenishes stocks materials and perform inventories;
• Support filing of experimental documentation.

Education
• DEC in laboratory methods, profile life sciences (or similar), B.Sc. in life sciences.

Main Requirements
• Ideally, >1-year experience in laboratory;
• Experience in working with a biological safety cabinet using sterile conditions;
• Experience in working with PBMC (isolation by Ficoll, cryopreservation, thawing, counting with hemocytometer);

• Experience in cell culture (cell lines);
• Experience in a GLP/GCLP environment an asset;
• Organized and rigorous in the conduct of their work;
• Good record keeping skills and attention to detail;
• Dynamic, motivated, troubleshooting skills, teamworker, interest and ability with precision instrumentation, flexibility in a fast paced environment;

• English proficiency.

Special Conditions

• Must accept to perform duties activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV.

• Occasionally, work schedule may be adapted to accommodate operational needs.

Description du poste

CellCarta est à la recherche d’un(e) associé(e) de recherche très motivé(e) et enthousiaste qui possède une expérience pratique des immunoessais (MSD et ELISA). Le (la) candidat(e) jouera un rôle clé dans l’analyse d’échantillons sur une variété de fluides biologiques et d’échantillons d’étude de tissus en suivant les bonnes pratiques de laboratoire (BPL) et les procédures opérationnelles normalisées (PON). Le (la) candidat(e) peut également être amené à effectuer l’optimisation/la qualification et la validation de méthodes.

Responsabilités principales

• Traiter et analyser des échantillons biologiques par immunoessais (ELISA et MSD)
• Évaluer et valider les essais immunologiques (ELISA et MSD) au besoin
• Exécuter le travail conformément aux procédures établies
• Tenir à jour la documentation relative à l’étude conformément aux BPL et aux directives réglementaires.
• Contrôler le rendement de l’équipement et consigner les activités dans les journaux de bord
• Effectuer des tâches générales de laboratoire
• Préparer et réviser la documentation relative aux expériences
• Effectuer des travaux dans un environnement BPL et, à l’occasion, dans un environnement de niveau de confinement 2 (CL2).

Formation

• B.Sc. ou M.Sc. en sciences de la vie, biochimie (ou équivalent)

Exigences principales

• Minimum d’un an d’expérience pertinente
• Connaissance et expérience des tests ELISA et MSD sont fortement souhaitées
• Connaissance et compréhension de la réglementation en matière de BPL
• Excellentes compétences en matière de gestion du temps et d’organisation pour respecter les délais dans un environnement en constante évolution
• Capacité à travailler de manière indépendante, autonome et dans une équipe
• Capacité à tester avec précision un grand nombre d’échantillons avec une répétabilité fiable
• Bonne tenue de dossiers, attention aux détails et engagement à réaliser un travail de bonne qualité.
• Expérience de travail dans l’industrie

_________________________________________________________________________________

Position Summary

CellCarta is seeking a highly motivated and enthusiastic Research Associate with hands-on experience in immunoassays (MSD and ELISA). This individual will play a key role in analyzing samples on a variety of biological fluids and tissue study samples following Standard Operating Procedures (SOP) and Good Laboratory Practices (GLP). They can also be required to perform method optimization/qualification and validation.

Main Responsibilities

• Process and analyze biological samples by Immunoassay (ELISA and MSD)
• Evaluate and validate Immunoassay (ELISA and MSD) as needed
• Execute work as per established procedures
• Maintain study-related documentation according to GLP and regulatory guidance
• Monitor the performance of equipment and recording activities in logbooks
• Perform general laboratory duties
• Prepare and review documentation for experiments
• Perform work in a GLP environment and occasionally in a containment level 2 (CL2) environment

Required Skills and Experience

• B.Sc. or M.Sc. in life sciences, biochemistry (or equivalent)
• A minimum of 1 year of relevant experience
• Knowledge and experience with ELISA and MSD assays are highly desired
• Knowledge and understanding of GLP regulations
• Excellent time management and organizational skills to meet deadlines in a fast-paced, changing environment
• Ability to work independently, autonomously and as part of a team
• Skill to accurately test large numbers of samples with reliable repeatability
• Good record keeping, attention to details and commitment to achieve good quality work
• Experience working in industry

Sommaire du poste
L’assistant/e de recherche mène et effectue des expériences de développement utilisant plusieurs technologies (cytométrie de flux, immuno-essais, ELISpot, culture cellulaire…). 
À cette fin l’assistant/e de recherche prépare la documentation nécessaire à l’expérimentation, prépare les réactifs/ échantillons et exécute le travail de laboratoire. Son rôle est aussi de voir au bon maintien de la documentation de son projet afin de respecter les BPL et d’écrire les procédures opératoires normalisés (PON).

Principales responsabilités
• Exécuter des expériences de laboratoire impliquant la culture cellulaire, la cytométrie de flux, des immuno-essais (ELISA, MSD) et de l’ELISpot;

• Travailer avec différents échantillons humains: Sang complet, PBMC, moelle osseuse, ect;
• Préparer les réactifs et échantillons nécessaires aux expérimentations;

• Préparer et maintenir la documentation expérimentale et du projet (BPL);

• Écrire les PON découlant du développement de méthode effectué;

• Effectuer le développement de méthode dans les temps prescrits;

Formation requise
• B.Sc. ou M.Sc. en sciences de la vie

Compétences et expérience requises
• Idéalement 5 ans d’expérience de laboratoire en industrie;

• Expérience et expertise pour le travail avec des cytomètres de flux (>6 couleurs), à établir les paramètres et faire la résolution de problème;
• Expérience de travail avec une hotte de biosécurité dans des conditions stériles;
• Expérience de travail avec les PBMC (isolement par Ficoll, cryopréservation, décongélation, comptage avec hémocytomètre);

• Expérience de culture cellulaire (lignées cellulaires);
• Expérience dans un environnement BPL/GCLP, un atout;
• Être organisé et rigoureux dans son travail;
• Capacité à bien documenter son travail et souci du détail;
• Résolution de problèmes

• Dynamique, et motivé/e, pensée analytique, bonne communication, flexibilité et adaptabilité, travail d’équipe,

Notes Particulières
• Travail en niveau de biosécurité 1 et 2, avec des échantillons biologiques qui peuvent être naturellement ou expérimentalement infectés avec des virus cotés biosécurité tels que HIV, HCV et CMV.

• L’organisation du travail et des opérations peut amener des changements d’horaire occasionnels.

Als globale onderzoeksorganisatie in de biofarmaceutische industrie, voorziet CellCarta (Vroeger: Caprion – Histogenex) toegang tot een breed aanbod van biomarker platforms en services. Wij werken samen met onze partners om de meest complexe wetenschappelijke testen uit te voeren. Zo leveren we persoonlijke biomarker oplossingen om steeds verder te gaan in de eindeloze mogelijkheden van precieze medicatie.

Wij bieden onze services op globale schaal aan via onze laboratoria in de US, Canada, België, China en Australië, waar we expertise hebben op vlak van histopathology, immune monitoring, proteomics, genomics en sample logistics. Wij ondersteunen farmaceutische en biotechnische bedrijven in het onderzoek en de ontwikkeling van nieuwe innovatieve medicatie voor de behandeling van kanker en immuniteitsziektes.

Werkend onder strenge kwaliteit en wettelijke vereisten, streven wij ernaar om een verschil te maken in de toekomstige behandelingen die we aan patiënten kunnen bieden.

CellCarta maakt gebruik van zijn sterkte ervaring in kankeronderzoek om het hele spectrum te ondersteunen van biomarker services, inclusief biomarker ontdekking in de onderzoeksfase, tumor profilering en biomarker monitoring in klinische studies en registratiestudies voor begeleidende diagnostiek, patiënten diagnoses en de ontwikkeling van nieuwe technieken en testen voor tumor analyses en de voorspelling van behandelingsrespons. Het bedrijf is de brug tussen onderzoek, klinische studies en diagnoses.

Momenteel zijn we op zoek naar een Junior Sales Analist om ons team te versterken.

Departement: Assay Development

Gebaseerd in

Wirlijk, Antwerpen (Belgie)

Belangrijkste taken

• Je werkt nauw samen met verschillende departementen (accounting, imaging, assay development) binnen CellCarta-HistoGenex.

• Opstellen van offertes obv ‘Request for Proposals’ (RFP) en opvolgen van contracten met farmaceutisch bedrijven.

• Ondersteuning bij de maandelijkse facturatiecyclus.

• Maandelijkse rapportering van sales gerelateerde cijfers naar het management.

• Analyseren van sales gerelateerde informatie over onze grote klanten.

• Aanspreekpunt voor alle ERP/CRM gerelateerde vragen (Salesforce).

• Je organiseert en communiceert prjisberekeningen van nieuwe assays en ondersteunt prijsonderhandelingen met vendors.

• Je denkt mee na over het opzetten en begeleiden van nieuwe processen binnen het assay development management team.

Profiel

• Als Junior Sales Analist binnen het assay development team beschik je bij voorkeur over een masterdiploma in een wetenschappelijke richting (Biochemie, Biomedische wetenschappen, Biologie, Farmaceutische wetenschappen, ea.) of je bent gelijkgesteld door ervaring

• Je hebt een gezonde interesse in financieel/administratief werk, ervaring hierin is een pluspunt. • Ervaring met ERP en CRM is een pluspunt

• Je werkt gestructureerd, pragmatisch en oplossingsgericht

• Verder ben je communicatief, klantvriendelijk en een echte teamspeler

• Je kan prioriteiten stellen en behoudt het overzicht op drukke momenten

• Uitstekende kennis van Microsoft Office en in het bijzondere Excel

• Je spreekt en schrijft vloeiend Engels

Aanbod

• Tijdregeling: Voltijds
• Dienstregeling: Dagwerk
• Je komt in een dynamisch groeiend bedrijf terecht waar we werken volgens de 38 uren werkweek
• Om de woon/werk balans in evenwicht te helpen houden geven we je, boven het wettelijk verlof, nog extra vakantiedagen
• Je krijgt een competitief loon en extralegale voordelen

Wij bieden een boeiende en uitdagende functie bij een multinationale speler waar klantgerichtheid en innovatie met stip aangeduid staan. Je krijgt een doorgedreven on-the-job opleiding.

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly HistoGeneX - Caprion) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

For our main HistoGeneX site – situated in Wilrijk, Antwerp (Belgium) we currently are recruiting a Proposal Development Manager (Clinical Trials)

Major responsibilities

• Your main task will be to prepare detailed budgets for clinical studies in the oncology field. You will – together with your colleagues - review and analyze the request for proposals coming from our pharma and biotech clients, clarify details in close contact with the customers, and prepare a final budget for the clinical study. You will track these opportunities in a CRM database and monitor the progress of the proposals until awarded.
• You will be a contributor in the price setting process and maintain a detailed price book for the various service offerings.
• You will be involved in requests for information from our customers.
• You will interact closely with the global business development teams and the operational teams in the laboratories to translate our service offerings into correct budget proposals for our customers.

Background

• Master in Biosciences (Biomedical Sciences, Biochemistry, Biotechnology, Biology, Pharmaceutical Sciences) or similar by experience

• Familiar with laboratory testing and laboratory processes is a plus

• Project management, understanding of clinical trials and the processes involved

• Strong affinity and a key interest to work with numbers

• Detailed and structured in your approach

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth
• A company that is fit for the future
• A competitive salary and benefits
• A great team you can work with

Position Summary

Caprion is seeking a  Program Manager to organize and coordinate scientific programs. The Program Manager provides strategic guidance to teams and Principal Scientists to align with the company’s objectives.

Main Responsibilities

• Provides support at the project-level activity to ensure the program goals are met by providing a decision-making capacity that cannot be achieved at project level;
• Provides the Principal Scientists with a program perspective when required, or as a sounding board for ideas and approaches to solving project issues that have program impacts;
• Monitors overall project objectives, milestones and timetables for achieving intermediate and overall project goals;
• Identifies and manages cross-project dependencies and provides support in prioritizing projects when needed;
• Sets review dates to ensure that projects remain on target;
• Proactively assesses program performance; Will coordinate and monitor progress across all projects and establish a formal reporting structure for overall program progress;
• Develops and monitors deadlines and budgets overall for program milestones;
• Resolves issues and initiates appropriate corrective actions (or interventions) wherever gaps in the program are identified;
• Performs tracking of deliverables in conjunction with client and internal customers;
• Conducts ongoing teleconferences with the client, managing the agenda and meeting minutes;
• Provides timely notification to all appropriate parties with deviations from timelines and/or deliverables;
• Conducts regular communication with team members, formal and informal, regarding study status or any other changes;
• Performs capacity planning for upcoming programs (as well as projects).

Education

MSc in life science

Main Requirements

• Minimum of 3 to 5 years of experience in a CRO or in biotechnology as a Project Manager;
• Excellent multitasking and tracking skills;
• Effective leadership, interpersonal and communication skills;
• Ability to find ways of solving or pre-empting problems;
• Knowledge of proteomics and/or the immune monitoring field;
• Knowledge of industry standards for the conduct of analytical studies;
• Knowledge of regulatory requirements for the conduct of analytical studies in support of clinical trials (exploratory vs secondary/primary endpoints);
• Ability to create a sense of community amongst the members of the project teams;
• Excellent knowledge of project management and budgeting;
• Sufficient seniority and credibility to advise project teams on their projects in relation to the program;
• Proficiency with MS Project and Excel;

Summary

CellCarta is looking for a digital marketing specialist to help grow its businesses and client base. Reporting to the Marketing Director, you will lead and execute all digital campaigns using marketing automation and CRM tools. The ideal candidate is a self-starter and strives on delivering business results while continuously improving. If you are dynamic and creative and can coordinate deliverables in a fast-pace environment in a rapidly growing industry, this role is for you. As a member of the Sales Operations and Marketing team, you will also help educate and support our internal teams on new digital advertising/marketing platforms initiatives and provide support to the marketing team on various campaigns and advertisements initiatives to promote breakthrough work in the CRO industry.

Main Responsibilities

• Work closely with the Marketing Director and Scientific Content Specialist to develop and execute all digital campaigns

• Lead our marketing automation efforts, manage the execution of B2B digital campaigns to achieve CellCarta’s key objectives using Salesforce and PARDOT

• Support and execute B2B digital media campaigns (SEM/SEO, Paid Social & Display, Email Marketing and Social Medias) to increase web traffic and lead generation

• Develop and maintain campaign architecture in PARDOT for various business scenarios

• Use automation to plan and execute PARDOT drip campaigns to support our lead nurturing strategy

• Create and manage automation workflows and segment lists to tailor campaigns for targeted audiences across specific market segments

• Analyze and report campaign performance; develop A/B test plans to improve response.

• Collaborate with marketing team to develop and maintain a global campaign calendar

• Develop unique creative digital content in various formats (videos, animated gif, banners, infographics) and ability to edit content with calls to action that drives engagement     

• Responsible for the development, maintenance, and improvements of the corporate website, and provide recommendations to improve customer journey

• Report on key campaign metrics, including creating ad hoc and monthly reports

• Perform campaign management tasks as needed

 
Qualifications and Requirements

• Bachelor’s degree in Marketing, Digital Marketing or relevant field

• Minimum of 2-4 yrs of experience in a full time B2B digital /inbound marketing role

• Expert Pardot/Salesforce user

• Experience in creating and executing multiple campaigns with understanding of customer journey (understanding of the drug development process is an asset)

• Knowledge of the pharmaceutical industry and CRO industry, a strong asset

• Strong experience in executing and analyzing SEO/SEM, display/paid media, social media (LinkedIN, Facebook, Instagram, Twitter, YouTube, Vimeo) and email marketing campaigns

• Strong expertise in web development project management experience, CMS experience (WordPress and other CMS)

• Well versed in data analytics (e.g., Google Analytics, Google Search Console, SEMRush etc.)

• Google Analytics Certification and Google Ads Certification a plus

• Advanced HTML/CSS knowledge

• Strong expertise with Adobe Creative Suite/Creative Cloud – Photoshop, Illustrator, InDesign

Skills

• Ability to take direction with minimal supervision, work independently and is a positive team player

• Track record of strong execution and delivery of commitments

• Ability to write, edit and adapt compelling content for digital channels (an asset)

• Strong attention to detail and ability to respond to situations quickly

• Strong analytical and project management skills

• Excellent verbal and written communication skills

Position Summary

The Data Analyst performs a variety of analytic functions within the CellCarta Precision Medicine Inc. Flow Cytometry Department. These functions include analysis and reporting of flow cytometry data and data from other platforms as needed.  The analyst works under the supervision of the Associate Director of the Data Analysis Unit to ensure accurate and timely completion of data analysis. Maintains study-related documentation as per GLP/GCLP and regulatory guidance.

The position requires to be available two weekends per month, from Wednesday to Sunday on the day shift

Key Responsibilities

• Analyzes data as per CellCarta'S SOPs;
• Reviews data analyzed by other analysts and reports data as needed or instructed;
• Assists as required in the organization of study data and associated information required for interim and final study reports;
• Involved in implementation of new analytical/statistical tools to increase the data analysis throughput.

Education

M.Sc. or PhD in immunology.

Required Expertise and Skills

• 2 years of experience data analysis in immunology
• Multiparametric flow cytometry statistical analysis (FlowJo and BD FACSDiva software);
• Good communication skills in English and knowledge of French an asset;
• Strong computer skills and significant experience with Microsoft Excel, Word, and PowerPoint;
• Detail-oriented person;
• Ability to work in a fast pace environment,
• Ability to work autonomously and in a structured environment

Sommaire

L’analyste de données en immunologie occupe différentes fonctions au sein du département d'analyse de données. C’est fonctions incluent l’analyse et la production de rapports concernant les données en cytométrie en flux et de données provenant de d’autres plateformes. Le titulaire du poste se doit de maintenir la documentation en lien avec les différentes études à jour, selon les normes réglementaires tel que GLP/GCLP. Finalement, l’analyste de données relèvera de la directrice adjointe de l’unité d’analyse.

Principales Responsabilités

• Analyse les données selon les SOP;
• Révise les données analysées par ses pairs et produit des rapports selon les exigences du département;
• Assiste lorsque requis dans l’organisation des données sur les études et de l’information requise pour les rapports d’études intérimaires et les rapports d’études finaux;
• S’implique dans l’implantation de nouveaux outils analytiques et statistiques, afin d’améliorer l’efficacité du département d’analyse.

Éducation

• Maîtrise en immunologie

Expérience

• 0-6 mois d’expérience en analyse de données en immunologie;
• Solides connaissances de la cytométrie en flux multi-paramètres (panels de plus de six couleurs);
• Aptitudes en analyses statistiques;
• Connaissance avancée de l’anglais écrit;
• Connaissance des systèmes FlowJo, FACSDiva, R, et Prism;
• Solides compétences avec la suite Office;
• Être orienté vers les détails;
• Habileté à travailler dans un environnement changeant;
• Habileté à travailler de façon autonome et dans un cadre défini.

Laboratory Technician

Summary
The laboratory technician provides support in experiment preparation (solutions, consumables, labels) and in samples and solution preparation. He participates in the maintenance and upkeep of equipment, in the reception of reagent and material, and inventories. The laboratory technician is working in a GLP environment.

Main Responsibilities
• Performs sample preparation such as cell isolation from blood sample, cryopreservation, thawing, counting;
• Provides general support in experiment preparation such as plastic identification and labels preparation;
• Prepares solutions and reagent aliquots;
• Performs equipment maintenance, calibration, and cleaning;
• Replenishes stocks materials and perform inventories;
• Performs files archiving.

Education
• DEC in Laboratory Technology, preferably with a biotechnology specialization.

Main Requirements
• 1-year experience in laboratory;
• Experience in working with a biological safety cabinet using sterile conditions;
• Experience in working with PBMC (isolation by Ficoll or CPT, cryopreservation, thawing, counting with hemocytometer);
• Experience in a GLP/GCLP environment an asset;
• Organized and rigorous in the conduct of their work;
• Good record keeping skills and attention to detail;
• Dynamic, and motivated.

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia.  Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting a Business/technical IT Analyst (Software implementation)

Department: IT

Based in

Wilrijk, Antwerp (Belgium)

Function

We are looking for a Business/technical IT Analyst (Software implementation) who will focus on translating the needs from the operational teams to requirements for the LIMS development team. This role will play a crucial part in the build out of our company’s LIMS system.

Major responsibilities

• Support the operational team in translating operational processes to user requirements (liaison between operations and IT)
• Make recommendations for solutions or improvements to operational processes that can be accomplished through new technology or alternative use of existing technology (e.g. ELN)
• Project follow-up from the operational end from user requirement definition to implementation of new functionality/software
• Align priorities over the different operational teams
• Align set requirements with project deliverables
• Support data visualization solutions

Background

• A minimum of Bachelor's degree in sciences (Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Medicine,…) required; advanced degree is preferred
• At least 3 years of experience in translation of operational processes to software user requirements in a GxP environment
• Fluent in English both written and spoken. Fluency in Dutch is considered an advantage

        What we can offer

• A dynamic and rapidly changing global environment allowing personal growth
• A company that is fit for the future
• A competitive salary and benefits
• A great team you can work with

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting a Quality Assurance Manager

Department: Quality Assurance

Based in

Wilrijk, Antwerp (Belgium)

Function

The QA Manager works as member of the Quality Assurance team, ensuring that all activities are performed in accordance with GCP, GCLP, CAP/CLIA and ISO15189.

Major Responsibilities

• Assist in defining quality procedures in conjunction with the operational teams (SOPs, forms, work instructions, policies)

• Assist in administrative duties related to the QA section

• Perform internal audits

• Participate in sponsor audits and regulatory inspections (preparation, hosting and follow-up actions)

• Participate in review of non-conformities, deviations and complaints and support to related investigations

• Participate to the CAPA review process

• Work with relevant departments to ensure timely closure of quality action plans

• Actively contribute to continuous improvement and quality awareness initiatives

• Contribute to the implementation of new quality standards (ISO13485) 

• Ensure registration of QA related training

• Contribute to the preparation of management reviews

• Assist in the follow-up of KPI’s

• Contribute actively in the risk management activities of the company

Background

• Bachelor or Master Degree in life sciences with preferably 3 years of experience in a quality assurance role in a laboratory or an IVD manufacturing environment

• Advanced knowledge, orally and in writing of English, knowledge of Dutch and French is a plus

• Excellent organizational skills

• Dynamic personality, a true team player with good interpersonal skills

• Analytical thinker with a process-oriented mindset

• Ability to work independently

• Good documentation skills (accurate, attention to details)

• Experience related to quality and regulatory aspects of in vitro diagnostic devices (ISO13485, IVDD, IVDR and/or FDA IDE and PMA regulations) is an advantage

• Willingness to travel

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth

• A company that is fit for the future

• A competitive salary and benefits

• A great team you can work with

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia.  Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting an IT Senior Director MSP Governance Validation & Lab End User Support

Department: IT

Based in

Preferably Naperville (US). Alternatively Montréal (Canada) or Wilrijk, Antwerp (Belgium)

Major responsibilities

• Develop and implement (IT) solutions & services that support a global connected (cloud) platform across multiple regions and countries
• Advise on best-fit (IT) services and providers to IT leadership and business stakeholders to support the IT strategy and the business
• Advise and implement on best-fit security services and process for a global company covering multiple regions and countries
• Advice on optimal risk based delivery of validation services
• Implement and support the IT strategy around lab & end-user services on a global scale
• Lead yearly financial planning and business case follow up for your area
• Define yearly (application) IT service roadmap and deliver upon promises with both internal and external vendors across the world
• Shape the team using internal and external vendors to fit the needs

Background

• Advanced degree (Bachelor’s level or higher in science or IT) with at least 5 years of experience in similar roles with a proven track record of delivering global critical implementations
• Proven experience with multiple technologies including on-premise and cloud environments
• Proven experience in integration of multiple service deliveries, including helpdesk, governance, validation and end-user support
• Proven experience in working with internal teams and external vendors in different sourcing models
• An understanding of typical laboratory workflows in the chemical, pharmaceutical, environmental or similar industries would be advantageous as would knowledge of Laboratory Informatics
• A wide degree of creativity and initiative is expected. This includes helping the team operationally where needed
• Excellent communication skills, both verbal and written
• Fluent in Dutch and English both written and spoken
• Well organized, results orientated team player capable of working under a minimum of supervision.
• Participate in the validation of these applications
• Having an entrepreneurial mindset is key
• Understand the needs and requirements from internal departments and translate them to applications
• Be able to see the trends in the market and translate it to new services for the company
  arta

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth
• A company that is fit for the future
• A competitive salary and benefits
• A great team you can work with

Als globale onderzoeksorganisatie in de biofarmaceutische industrie, voorziet CellCarta (Vroeger: Caprion – Histogenex) toegang tot een breed aanbod van biomarker platforms en services. Wij werken samen met onze partners om de meest complexe wetenschappelijke testen uit te voeren. Zo leveren we persoonlijke biomarker oplossingen om steeds verder te gaan in de eindeloze mogelijkheden van precieze medicatie.

Wij bieden onze services op globale schaal aan via onze laboratoria in de US, Canada, België, China en Australië, waar we expertise hebben op vlak van histopathology, immune monitoring, proteomics, genomics en sample logistics. Wij ondersteunen farmaceutische en biotechnische bedrijven in het onderzoek en de ontwikkeling van nieuwe innovatieve medicatie voor de behandeling van kanker en immuniteitsziektes.

Werkend onder strenge kwaliteit en wettelijke vereisten, streven wij ernaar om een verschil te maken in de toekomstige behandelingen die we aan patiënten kunnen bieden.

CellCarta maakt gebruik van zijn sterkte ervaring in kankeronderzoek om het hele spectrum te ondersteunen van biomarker services, inclusief biomarker ontdekking in de onderzoeksfase, tumor profilering en biomarker monitoring in klinische studies en registratiestudies voor begeleidende diagnostiek, patiënten diagnoses en de ontwikkeling van nieuwe technieken en testen voor tumor analyses en de voorspelling van behandelingsrespons. Het bedrijf is de brug tussen onderzoek, klinische studies en diagnoses.

Momenteel zijn we op zoek naar een Laboratorium Technoloog (m/v) om ons team te versterken.

Departement: IHC en FISH waar de immuno-histochemische en fluorescente in situ hybridisatie technieken worden toegepast.

Gebaseerd in 

Wirlijk, Antwerpen (Belgie)

Belangrijkste taken (Na een interne opleiding zal je worden ingezet voor)

• het uitvoeren van gespecialiseerde immunohistochemische en fluorescente kleuringen, en in situ hybridisatie analyses en dit zowel manueel als op verschillende automatische kleurtoestellen

• de controle over de werking van de toestellen en het signaleren van storingen

• het opvolgen van de laboprocessen en de registratie van gegevens in het labo informatiemanagementsysteem (LIMS)

• de documentatie van het uitgevoerde labowerk

• het assisteren bij de data interpretatie  

Profiel

• Je heb een diploma Professionele bachelor (Medische, Farmaceutische of Biomedische laboratorium technologie of Biochemie)

• Voorafgaande ervaring in een laboratorium is een pluspunt • Je kan vlot met de computer overweg (Word, Excel)

• Ervaring met een LIMS systeem is mooi meegenomen

• Je bent flexibel, communicatief en werkt graag in teamverband 

• Basiskennis Engels is noodzakelijk

• Je zal werken binnen een ISO kwaliteitssysteem, wat vereist dat je nauwkeurig en gedocumenteerd kan werken

Aanbod

• Contract van onbepaalde duur

• Tijdregeling: Voltijds

• Dienstregeling: Dagwerk

• Je komt in een dynamisch groeiend bedrijf terecht waar we werken volgens de 38 uren werkweek

• Om de woon/werk balans in evenwicht te helpen houden geven we je, boven het wettelijk verlof, nog extra vakantiedagen

• Je krijgt een competitief loon en extralegale voordelen

As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting an IT Manager Security

Department: IT

Based in

Global role - Preferably Wilrijk, Antwerp (Belgium) or Montréal (Canada)

Major responsibilities

• Develop and implement security solutions that support a global connected (cloud) platform across multiple regions and countries
• Advise on best-fit (IT) solutions to IT leadership and business stakeholders to support the IT strategy and the business
• Implement and support security related platforms and integrations
• Advise and implement on best-fit security solutions in line with industry best practices such as ISO27001/2, ISO20017 and the NIST framework for a global company covering multiple regions and countries
• Support yearly financial planning and business case follow up for your area
• Support yearly (application) IT security roadmap and deliver upon promises with both internal and external vendors across the world

Background

• Advanced degree (Bachelor’s level or higher in science or IT) with at least 2-3 years of experience in similar roles with a proven track record of delivering security implementations to the above described standards
• Having CISO certifications is key
• Proven experience in setting up security on data platforms and toolings
• Proven experience with multiple technologies including on-premise and cloud environments
• Proven experience in security integrations of multiple platforms, including application and data flow optimizations
• Proven experience in working with internal teams and external vendors in different sourcing models
• An understanding of typical laboratory workflows in the chemical, pharmaceutical, environmental or similar industries would be advantageous as would knowledge of Laboratory Informatics
• A wide degree of creativity and initiative is expected. This includes helping the team operationally where needed
• Excellent communication skills, both verbal and written
• Fluent in Dutch and English both written and spoken
• Well organized, results orientated team player capable of working under a minimum of supervision
• Participate in the validation of these applications
• Having an entrepreneurial mindset is key
• Understand the needs and requirements from internal departments and translate them to applications
• Be able to see the trends in the market and translate it to new services for the company

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth
• A company that is fit for the future
• A competitive salary and benefits
• A great team you can work with

As a global Research Organization to the biopharmaceutical industry, CellCarta ( formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting an IT Manager Data Reporting & Analysis

Department: IT

Based in

Wilrijk, Antwerp (Belgium)

Major responsibilities

•  Develop and implement data integration solutions that support a global connected (cloud) platform across multiple regions and countries
•  Advise on best-fit (IT) solutions to IT leadership and business stakeholders to support the IT strategy and the business
•  Implement and support all data related platforms and integrations
•  Advise and implement on best-fit data solutions, integration tooling and platforms for a global company covering multiple regions and countries
•  Support yearly financial planning and business case follow up for your area
•  Support yearly (application) IT roadmap and deliver upon promises with both internal and external vendors across the world

Background

•  Advanced degree (Bachelor’s level or higher in science or IT) with at least 2-3 years of experience in similar roles with a proven track record of delivering data integrations
•  Proven experience in setting up data platforms and toolings
•  Proven experience with multiple technologies including on-premise and cloud environments
•  Proven experience in integration of multiple platforms, including application and data flow optimizations
•  Proven experience in working with internal teams and external vendors in different sourcing models
•  An understanding of typical laboratory workflows in the chemical, pharmaceutical, environmental or similar industries would be advantageous as would knowledge of Laboratory Informatics
•  A wide degree of creativity and initiative is expected. This includes helping the team operationally where needed
•  Excellent communication skills, both verbal and written
•  Fluent in Dutch and English both written and spoken
•  Well organized, results orientated team player capable of working under a minimum of supervision
•  Participate in the validation of these applications
•  Having an entrepreneurial mindset is key
•  Understand the needs and requirements from internal departments and translate them to applications
•  Be able to see the trends in the market and translate it to new services for the company

What can we offer

• A dynamic and rapidly changing global environment allowing personal growth
• A company that is fit for the future
• A competitive salary and benefits
• A great team you can work with

Summary

The Associate Director of Supplier Quality is responsible for developing and deploying quality processes and systems associated with managing suppliers. This involves developing policies, processes, procedures and systems for approving and maintaining an approved list of qualified suppliers.

Responsibilities

• Primary interface with suppliers.
• Develops a range of tools for assessing suppliers (assessment of risk, audits, questionnaires).
• Develops and implements processes for determining risk level of suppliers and the necessary interactions to monitor the appropriate level of compliance.
• Develops systems and workflows to interacting with suppliers.
• Develops and maintains quality agreements with suppliers.
• Participates with sponsor and regulatory inspections to outline the supplier quality program.
• Serves as a subject matter expert on internal/external supplier quality related committees.
• Collaborates with key internal and external stakeholders to nurture process improvement.
• Develop and maintain a system for supplier complaints and Supplier Corrective Action Requests (SCAR).
• Demonstrates a commitment to the development, implementation and effectiveness of applicable quality processes as per IVDR, FDA, and other regulatory agency requirements.
• Make decisions related to work processes or operational plans and schedules in order to achieve program objectives established by senior management.

Education

• Minimum BA/BS in science or health-related discipline.

Requirements

• Minimum of 5 years' industry or related experience, 2 years of direct SQA experience, 2 years of audit experience.
• Deep knowledge and experience with supplier quality systems and ISO 13485, ISO15189 framework, GLP, GCP and CAP/CLIA requirements.
• Experience interfacing with suppliers and aligning on a quality agreement framework.
• Ability to merge business and compliance needs to achieve effective solutions.
• Knowledge of compliance requirements for different stages of development.
• Must have knowledge of applicable global regulations.
• Must have demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity.
• Excellent project management skills.

Sommaire du poste

Caprion est à la recherche d'un gestionnaire de programme afin d'organiser et de coordonner les programmes scientifiques. Le gestionnaire de programme fournit aux équipes et aux scientifiques principaux une orientation stratégique afin de les aligner sur les objectifs de l'entreprise.

Principales Responsabilités

• Fournit un soutien au niveau des activités du projet pour assurer que les objectifs du programme sont atteints;
• Fournit aux scientifiques principaux une perspective du programme, ou des d’idées et des approches pour la résolution des problèmes liés au projet qui ont un impact sur le programme;
• Fait le suivi des principaux objectifs des projets, identifie les jalons et s’assure du respect des échéanciers pour la réalisation des objectifs intermédiaires et principaux des projets;
• Identifie et gère les impacts entre différents projets et apporte un support dans la priorisation des ceux-ci;
• Fixe des dates d’évaluations afin que les projets maintiennent le cap sur les objectifs; 
• Évalue de façon proactive la performance du programme; coordonne et suit de près les progrès réalisés dans l’ensemble des projets et établit une structure de rapport officiel pour l'ensemble des progrès;
• Développe et surveille l’ensemble des échéanciers et des budgets pour les jalons du programme;
• Résout les problèmes et initie les actions correctives appropriées (ou interventions) là où les lacunes au programme sont identifiées;
• Effectue le suivi des livrables en collaboration avec les clients externes et internes;
• Effectue des appels téléconférences de manière continue avec le client, gère l'ordre du jour et les procès-verbaux;
• Signale rapidement à toutes les parties concernées des écarts aux échéanciers et/ou aux livrables;
• Communique régulièrement avec les membres de l'équipe, tant de façon formelle qu’informelle, sur l’avancement de l'étude ou concernant d'autres changements;
• Effectue la planification pour les programmes à venir (ainsi que pour les projets).

Éducation

• Maîtrise en science

Exigences Requises

• 3 à 5 années d’expérience dans un CRO ou biotechnologie en tant que gestionnaire de projet;
• Solide expérience en gestion de projets et de budgets;
• Connaissance des normes de l'industrie pour la réalisation d’études scientifiques;
• Connaissance des exigences réglementaires pour la réalisation d’études scientifiques à l'appui des essais cliniques (exploration vs critères d'évaluation primaires/secondaires);
• Maîtrise de MS Project et Excel;
• Aptitudes à suivre différents projets et à réaliser différentes tâches à la fois;
• Bonnes aptitudes en résolutions de problèmes;
• Fait preuve de solides aptitudes à communiquer avec ses pairs comme les clients, à établir de bonnes relations avec es collègues et démontre du leadership;
• Capacité à créer un esprit de communauté parmi les membres des équipes de projet.

Als globale onderzoeksorganisatie in de biofarmaceutische industrie, voorziet CellCarta (Vroeger: Caprion – Histogenex) toegang tot een breed aanbod van biomarker platforms en services. Wij werken samen met onze partners om de meest complexe wetenschappelijke testen uit te voeren. Zo leveren we persoonlijke biomarker oplossingen om steeds verder te gaan in de eindeloze mogelijkheden van precieze medicatie.

Wij bieden onze services op globale schaal aan via onze laboratoria in de US, Canada, België, China en Australië, waar we expertise hebben op vlak van histopathology, immune monitoring, proteomics, genomics en sample logistics. Wij ondersteunen farmaceutische en biotechnische bedrijven in het onderzoek en de ontwikkeling van nieuwe innovatieve medicatie voor de behandeling van kanker en immuniteitsziektes.

Werkend onder strenge kwaliteit en wettelijke vereisten, streven wij ernaar om een verschil te maken in de toekomstige behandelingen die we aan patiënten kunnen bieden.

CellCarta maakt gebruik van zijn sterkte ervaring in kankeronderzoek om het hele spectrum te ondersteunen van biomarker services, inclusief biomarker ontdekking in de onderzoeksfase, tumor profilering en biomarker monitoring in klinische studies en registratiestudies voor begeleidende diagnostiek, patiënten diagnoses en de ontwikkeling van nieuwe technieken en testen voor tumor analyses en de voorspelling van behandelingsrespons. Het bedrijf is de brug tussen onderzoek, klinische studies en diagnoses.

Momenteel zijn we op zoek naar een Biosample Operator om ons team te versterken.

Departement: Bio Sample Management

Gebaseerd in 

Wirlijk, Antwerpen (Belgie)

Functie

Wij hebben voor jou de unieke mogelijkheid om als schoolverlater of laborant(e) met ervaring bij ons aan de slag te gaan in de afdeling ‘Biosample Management’. Binnenkomende stalen worden geregistreerd in het 'Labo informatie management systeem', verplaatst van en naar hun bewaarlocaties en terug gestuurd naar de klant na analyse. Je werk hier is dus de basis waarop andere teams hun moleculaire en immunohistochemische technieken gaan toepassen. Daarnaast wordt ook onderzoek gedaan naar de verschillende parameters die de kwaliteit van de weefselstalen beïnvloeden. Je begrijpt dat dit werk cruciaal is om achteraf correcte en zo goed mogelijke analyseresultaten te kunnen produceren.

Profiel

• Voorafgaande ervaring in een laboratorium of een studie Medisch Secretariaat is een pluspunt maar geen vereiste
• Je kan vlot met de computer overweg (Word, Excel) en met een database of je bent bereid dit te leren
• Je bent communicatief en werkt graag in teamverband
• Je zal werken binnen een kwaliteitssysteem (ISO 15189:2012), wat vereist dat je nauwkeurig en gedocumenteerd werkt

Jobgerelateerde competenties

• De stalen ontvangen en controleren: De datum, het tijdstip van de afname, de gegevens van de persoon met een zorgbehoefte, ... registreren
• Administratie en documentenbeheer uitvoeren
• Werkplaats en materiaal desinfecteren, ordelijk en net houden. Het afval afvoeren/vernietigen

Persoonsgebonden competenties

• Leervermogen hebben
• Samenwerken als hecht team
• Zich kunnen aanpassen aan veranderende omstandigheden (flexibiliteit)
• Omgaan met stress
• Klantgerichtheid
• Plannen (= ordenen)
• Zelfstandig werken
• Contactvaardig zijn
• Zin voor nauwkeurigheid hebben
• Creatief denken (Inventiviteit)
• Regels en afspraken nakomen

Aanbod

• Contract van onbepaalde duur
• Tijdregeling: Voltijds
• Dienstregeling: Dagwerk
• Je komt in een dynamisch groeiend bedrijf terecht waar we werken volgens de 38 uren
werkweek
• Je zal deel uitmaken van een snel groeiend en innovatief bedrijf met goede
doorgroeimogelijkheden
• Om de woon/werk balans in evenwicht te helpen houden geven we je, boven het wettelijk
verlof, nog extra vakantiedagen
• Je krijgt een competitief loon en extralegale voordelen

Als globale onderzoeksorganisatie in de biofarmaceutische industrie, voorziet CellCarta (Vroeger: Caprion – Histogenex) toegang tot een breed aanbod van biomarker platforms en services. Wij werken samen met onze partners om de meest complexe wetenschappelijke testen uit te voeren. Zo leveren we persoonlijke biomarker oplossingen om steeds verder te gaan in de eindeloze mogelijkheden van precieze medicatie.

Wij bieden onze services op globale schaal aan via onze laboratoria in de US, Canada, België, China en Australië, waar we expertise hebben op vlak van histopathology, immune monitoring, proteomics, genomics en sample logistics. Wij ondersteunen farmaceutische en biotechnische bedrijven in het onderzoek en de ontwikkeling van nieuwe innovatieve medicatie voor de behandeling van kanker en immuniteitsziektes.

Werkend onder strenge kwaliteit en wettelijke vereisten, streven wij ernaar om een verschil te maken in de toekomstige behandelingen die we aan patiënten kunnen bieden.

CellCarta maakt gebruik van zijn sterkte ervaring in kankeronderzoek om het hele spectrum te ondersteunen van biomarker services, inclusief biomarker ontdekking in de onderzoeksfase, tumor profilering en biomarker monitoring in klinische studies en registratiestudies voor begeleidende diagnostiek, patiënten diagnoses en de ontwikkeling van nieuwe technieken en testen voor tumor analyses en de voorspelling van behandelingsrespons. Het bedrijf is de brug tussen onderzoek, klinische studies en diagnoses.

Momenteel zijn we op zoek naar een Laboratorium Technoloog Pre Analytische fase om ons team te versterken.

Departement: Pre Analytics

Gebaseerd in 

Wirlijk, Antwerpen (Belgie)

Functie

In de sectie ‘Pre-Analytische fase’ kunnen we een paar extra handen gebruiken. Hier worden binnenkomende stalen van verschillende oorsprong verwerkt die dan verder gekleurd en geanalyseerd worden in onze andere units. Je werk is dus de basis waarop andere teams hun moleculaire en immunohistochemische technieken gaan toepassen. Daarnaast wordt ook onderzoek gedaan naar de verschillende parameters die de kwaliteit van de stalen beïnvloeden. Je begrijpt dat dit een cruciale fase is om achteraf zo goed mogelijke analyseresultaten te kunnen produceren. We werken voornamelijk in het kader van klinische studies waarmee we onze bijdrage trachten te leveren in de ontsluiering van het kankerproces.

Profiel

· Voorafgaande ervaring in een laboratorium is een pluspunt; Voorafgaande ervaring met microtomie is een groot pluspunt

· Je kan vlot met de computer overweg (Word, Excel) en met een (LIMS-) database of je bent bereid dit te leren

· Je bent communicatief en werkt graag in teamverband

· Je zal werken binnen een kwaliteitssysteem (ISO 15189:2012), wat vereist dat je nauwkeurig en gedocumenteerd werkt

· Kandidaten gelijkwaardig in ervaring komen ook in aanmerking voor deze vacature

Jobgerelateerde competenties

· Talenkennis: NEDERLANDS (zeer goed) ENGELS (in beperkte mate)

· Werkervaring: beperkte ervaring

Persoonsgebonden competenties

· werkinstructies volgen

· bereid zijn tot leren

· nauwkeurig werken

· samenwerken

Aanbod

· Contract van onbepaalde duur

· Tijdregeling: Voltijds

· Dienstregeling: Dagwerk

· Je komt in een dynamisch groeiend bedrijf terecht waar we werken volgens de 38 uren werkweek

· Om de woon/werk balans in evenwicht te helpen houden geven we je, boven het wettelijk verlof, nog extra vakantiedagen

· Je krijgt een competitief loon en extralegale voordelen

Summary

Supports drug discovery across the biotechnology industry by performing complex cellular assay services on samples from patients, healthy donors, and various animal species. Most assays involve analyzing immune cells by flow cytometry to evaluate pre-clinical therapeutics, biomarkers, or drug activity in patients. Primarily involves hands-on laboratory work and documenting protocols, with additional time spent planning experiments, analyzing data, and presenting results as experience is gained.

Responsibilities

• Conducts complex research experiments including drug treatment, blood processing, cell stimulation, sample cryopreservation, sample staining and flow cytometry. Does not work directly with animals, but handles blood and other primary cell sources from humans and species including mouse, rat, canine, monkey, etc.
• Prepares and reviews documents for laboratory assay work including protocol worksheets. Maintains all records relevant to tasks performed in a research laboratory including a detailed notebook.
• Assists in experiment planning and related activities including scheduling, ordering, and preparation of reagents.
• As experience is gained, analyzes data from experiments and formats graphs, figures, and technical reports to present to supervisors or clients.
• As experience is gained, trains other laboratory members on various complex experimental methods.

Education

• Bachelor's or Master's degree in Life Sciences, preferably Immunology, Cell/Molecular Biology or other Biomedical Sciences

Experience and Skills

• Minimum of 1 year experience in a biomedical research lab (academic or industry).
• Experience working with primary mammalian cells is preferred. In particular, treating or processing blood, cryopreserving cells, working with biohazardous materials in a sterile BSL2 environment, performing cell culture, staining and analyzing cells by flow cytometry are relevant experiences.
• Ability to understand and adhere to laboratory guidelines, and local, state, and federal health and safety procedures.
• Good organizational and documentation skills.
• Team player and proficient communicator using email, chat messaging, and video messaging.

Position Summary

Caprion is seeking a  Program Manager to organize and coordinate scientific programs. The Program Manager provides strategic guidance to teams and Principal Scientists to align with the company’s objectives.

Main Responsibilities

• Provides support at the project-level activity to ensure the program goals are met by providing a decision-making capacity that cannot be achieved at project level;
• Provides the Principal Scientists with a program perspective when required, or as a sounding board for ideas and approaches to solving project issues that have program impacts;
• Monitors overall project objectives, milestones and timetables for achieving intermediate and overall project goals;
• Identifies and manages cross-project dependencies and provides support in prioritizing projects when needed;
• Sets review dates to ensure that projects remain on target;
• Proactively assesses program performance; Will coordinate and monitor progress across all projects and establish a formal reporting structure for overall program progress;
• Develops and monitors deadlines and budgets overall for program milestones;
• Resolves issues and initiates appropriate corrective actions (or interventions) wherever gaps in the program are identified;
• Performs tracking of deliverables in conjunction with client and internal customers;
• Conducts ongoing teleconferences with the client, managing the agenda and meeting minutes;
• Provides timely notification to all appropriate parties with deviations from timelines and/or deliverables;
• Conducts regular communication with team members, formal and informal, regarding study status or any other changes;
• Performs capacity planning for upcoming programs (as well as projects).

Education

• MSc in life science

Main Requirements

• Minimum of 5 to 8 years of experience in a CRO or in biotechnology as a Project Manager;
• Excellent multitasking and tracking skills;
• Effective leadership, interpersonal and communication skills;
• Ability to find ways of solving or pre-empting problems;
• Knowledge of proteomics and/or the immune monitoring field;
• Knowledge of industry standards for the conduct of analytical studies;
• Knowledge of regulatory requirements for the conduct of analytical studies in support of clinical trials (exploratory vs secondary/primary endpoints);
• Ability to create a sense of community amongst the members of the project teams;
• Excellent knowledge of project management and budgeting;
• Sufficient seniority and credibility to advise project teams on their projects in relation to the program;
• Proficiency with MS Project and Excel;

Sommaire

Le scientifique principal chez CellCarta, au sein de l’unité d’affaire ImmuneCarta, est le lead scientifique pour les études en immune monitoring en support aux essais cliniques et aux études pré-cliniques. Le scientifique principal participe au design, au développement et à la validation des essais in vitro. De plus, il est le premier point de contact avec les Sponsors, leurs fournissant un sommaire des données, des présentations et des rapports. Il participe aussi au troubleshooting. Finalement, le scientifique principal est en charge des aspects scientifiques et réglementaires des études en immune monitoring.

Principales Responsabilités

• Supervise la planification et l'avancement des études et des projets sous sa responsabilité;
• Réalise et prépare des plans de travail spécifiques aux études et prépare les documents justificatifs pour les essais et les protocoles de suivi de la réponse immunitaire; discute avec la direction et obtient les approbations nécessaire, le cas échéant;
• Participe à l'élaboration de nouveaux tests in vitro selon les besoins des clients, y compris la phase qualification et validation des essais;
• Travaille en étroite collaboration avec le personnel du laboratoire (ex. assistants de recherche et techniciens) affectés à ses projets;
• Veille à ce que les projets soient réalisés selon les délais établis; à ce que les retards soient communiqués de manière proactive aux clients avec un plan d'action pour réduire les retards au minimum;
• Identifie les contraintes de ressources et travaille avec la direction pour les résoudre et améliorer la productivité;
• Participe à la préparation des présentations et des publications en collaboration avec les clients lorsque cela est possible;
• Interagit régulièrement avec les clients, les sites cliniques et la direction de CellCarta pour résoudre sans délai tout problème lié au projet à la satisfaction du client. Documente les interactions et les communications liées aux études;
• Participe activement à la préparation et la conduite des audits pour les clients ou les organismes réglementaires.

Formation Requise

• Ph.D. ou formation équivalente en sciences de la vie, de préférence en immunologie, virologie, microbiologie ou biologie moléculaire.

Expérience et Connaissances Exigées

• Un minimum de 5 ans d'expérience dans un poste équivalent en industrie;
• Connaissance en immunologie moderne et  être à jour concernant la littérature actuelle, les méthodologies de suivi de la réponse immunitaire et de la conception et de la réglementation des essais cliniques;
• Connaissance et expérience avec les techniques de cytométrie en flux et les applications génériques dans le domaine du suivi de la réponse immunitaire;
• Connaissance de la conception de tests, ainsi que la manipulation de données complexes d’essais de cytométrie multiparamétriques;
• Connaissance des analyses en milieu cellulaire pour suivre l’évolution des réponses immunitaires acquises et naturelles;
• Expérience de travail avec les logiciels d’analyse de données en cytométrie en flux et d’analyse statistiques;
• Connaissance et compréhension suffisantes des normes GLP et d'autres directives réglementaires pour effectuer des études GLP;
• Excellentes aptitudes de communication avec des collaborateurs internes et les clients;
• Expérience en gestion de projets et faire preuve de solides aptitude en planification et organisation;
• Parle couramment le français et l'anglais (écrit et parlé).
• Approche de travail méthodique et systématique;
• Capable d’établir des priorités;
• Démontre et applique un niveau avancé de compréhension et de compétences analytiques pour interpréter les données et en tirer des conclusions dans les objectifs du projet;
• Démontre un esprit critique et créatif;
• Communique clairement et avec confiance et possède d'excellentes compétences interpersonnelles;
• Capacité à travailler sur plusieurs tâches en même temps dans un environnement dynamique.

Conditions de travail

• Doit être disposé à exercer des fonctions ou à superviser des activités dans des installations de niveau de sécurité biologique (NSB) 1 ou 2 où les échantillons biologiques peuvent être soit naturellement ou expérimentalement infectés par des virus potentiellement dangereux tels que le VIH, le VHC ou le CMV.

____________________________________________________________________________________

Summary

The Principal Scientist is responsible for the overall conduct of studies in different immune-therapeutic area, overseeing experimental testing design, as well as formulating conclusions and recommendations for next steps. The incumbent has the ability to present CellCarta capabilities to clients in a compelling way demonstrating value and differentiation as support function to Business Development activities as well as presentation of results to Sponsor and scientific meetings. The incumbent is ensuring that the timelines and milestones of a study are met by proactively assessing foreseeing challenges, assessing impact of deviations and overall quality of the study conduct.

Main Responsibilities

• Oversees the planning and progress of studies and projects under her/his responsibility;
• Designs and prepares detailed study-specific work plans and support documentation for protocols and assays; discusses with management and obtains approval as appropriate;
• Participates in the development of new in vitro assays as per client needs, including the assay qualification and validation phase;
• Instructs laboratory personnel (e.g. research assistants and technicians) assigned to  her/his projects;
• Ensures that projects are conducted as per established timelines and delays are communicated in a proactive manner to clients with action plan to minimize the delays;
• Identifies resource constraints and inefficiencies and works with management to resolve;
• Prepares preliminary and final reports;  
• Ensures that all study-related data is appropriately maintained and archived;
• Participates in the preparation of presentations and publications in collaboration with clients when possible;
• Interacts regularly with clients, clinical sites and CellCarta management to address project issues in a timely manner and to the satisfaction of the client.  Documents study-related interactions and communications properly;
• Actively participates in the preparation and conduct of audits for clients or regulatory bodies.

Education

• Ph.D. or equivalent training in life sciences, preferably in immunology, virology, microbiology or molecular biology.

Experience and Skills Required

• A minimum of 2 years experience in an equivalent position in the industry or in an academic environment;
• Knowledge and experience with  multi-parametric flow cytometry techniques and its generic applications in the field of IM including testing design as well as handling complex data set of multi-color panels;
• Knowledge of modern immunology and kept abreast with current literature, IM methodologies and clinical trial design and regulations;
• Knowledge of cell-based assays to monitor adaptive and innate immune responses;
• Experience working with FlowJo, Pestle, Spice, Prism and Excel
• Knowledge and understanding of GLP regulations and other regulatory guidelines sufficient to carry out GLP studies;
• Experience in project management;
• Experience with client management;
• Strong communication ability;
• Approaches work methodically and systematically;
• Establishes priorities from among a number of demands;
• Demonstrates and applies advanced level of understanding and analytical skills to interpret data and draw conclusions within the project goals;
• Critical and creative thinker;
• Communicates clearly and confidently and has excellent interpersonal skills;
• Skilled at working in a fast-paced and multi-tasking environment.

More than your traditional CRO, we have a scientist-to-scientist approach and our culture is one of flexibility, accessibility, and service excellence. We are looking for science enthusiasts driven by innovation and eager to join a diversified team of scientists.

At CellCarta we are committed to giving our team the very best. Join us as we continue to expand internationally and be part of the future of precision medicine.

Summary

The Principal Scientist is responsible for the overall conduct of studies in different immune-therapeutic area, overseeing experimental testing design, as well as formulating conclusions and recommendations for next steps. The incumbent has the ability to present CellCarta capabilities to clients in a compelling way demonstrating value and differentiation as support function to Business Development activities as well as presentation of results to Sponsor and scientific meetings. The incumbent is ensuring that the timelines and milestones of a study are met by proactively assessing foreseeing challenges, assessing impact of deviations and overall quality of the study conduct. 

Main Responsibilities

• Oversees the planning and progress of studies and projects under her/his responsibility;
• Designs and prepares detailed study-specific work plans and support documentation for protocols and assays; discusses with management and obtains approval as appropriate;
• Participates in the development of new in vitro assays as per client needs, including the assay qualification and validation phase;
• Instructs laboratory personnel (e.g. research assistants and technicians) assigned to  her/his projects;
• Ensures that projects are conducted as per established timelines and delays are communicated in a proactive manner to clients with action plan to minimize the delays;
• Identifies resource constraints and inefficiencies and works with management to resolve;
• Prepares preliminary and final reports;  
• Ensures that all study-related data is appropriately maintained and archived;
• Participates in the preparation of presentations and publications in collaboration with clients when possible;
• Interacts regularly with clients, clinical sites and CellCarta management to address project issues in a timely manner and to the satisfaction of the client.  Documents study-related interactions and communications properly;
• Actively participates in the preparation and conduct of audits for clients or regulatory bodies.

Education

• Ph.D. or equivalent training in life sciences, preferably in immunology, virology, microbiology or molecular biology.

Experience and Skills Required

• A minimum of 2 years experience in an equivalent position in the industry or in an academic environment;
• Experience in leading a group of employees an asset;
• Strong knowledge and experience with multi-parametric flow cytometry techniques and its generic applications in the field of IM including testing design as well as handling complex data set of multi-color panels;
• Knowledge of modern immunology and kept abreast with current literature, IM methodologies and clinical trial design and regulations;
• Knowledge of cell-based assays to monitor adaptive and innate immune responses;
• Experience working with FlowJo, Pestle, Spice, Prism and Excel
• Knowledge and understanding of GLP regulations and other regulatory guidelines sufficient to carry out GLP studies;
• Experience in project management;
• Experience with client management;
• Strong communication ability;
• Approaches work methodically and systematically;
• Establishes priorities from among a number of demands;
• Demonstrates and applies advanced level of understanding and analytical skills to interpret data and draw conclusions within the project goals;
• Critical and creative thinker;
• Communicates clearly and confidently and has excellent interpersonal skills;
• Skilled at working in a fast-paced and multi-tasking environment.

Caprion Biosciences Inc. is a leading clinical research organization (CRO) laboratory in immune monitoring, protein characterization and tissue pathology solutions for immunotherapy and drug development. We are located in Montreal, California, Chicago, Belgium, UK, Australia and in China. Employees at Caprion are true scientific partners working together to enhance people’s health and quality of life.

Summary

The Principal Scientist is responsible for the overall conduct of studies in different immune-therapeutic area, overseeing experimental testing design, as well as formulating conclusions and recommendations for next steps. The incumbent has the ability to present Caprion capabilities to clients in a compelling way demonstrating value and differentiation as support function to Business Development activities as well as presentation of results to Sponsor and scientific meetings. The incumbent is ensuring that the timelines and milestones of a study are met by proactively assessing foreseeing challenges, assessing impact of deviations and overall quality of the study conduct. 

Main Responsibilities

• Oversees the planning and progress of studies and projects under her/his responsibility;
• Designs and prepares detailed study-specific work plans and support documentation for protocols and assays; discusses with management and obtains approval as appropriate;
• Participates in the development of new in vitro assays as per client needs, including the assay qualification and validation phase;
• Instructs laboratory personnel (e.g. research assistants and technicians) assigned to  her/his projects;
• Ensures that projects are conducted as per established timelines and delays are communicated in a proactive manner to clients with action plan to minimize the delays;
• Identifies resource constraints and inefficiencies and works with management to resolve;
• Prepares preliminary and final reports;  
• Ensures that all study-related data is appropriately maintained and archived;
• Participates in the preparation of presentations and publications in collaboration with clients when possible;
• Interacts regularly with clients, clinical sites and Caprion management to address project issues in a timely manner and to the satisfaction of the client.  Documents study-related interactions and communications properly;
• Actively participates in the preparation and conduct of audits for clients or regulatory bodies.

Education

• Ph.D. or equivalent training in life sciences, preferably in immunology, virology, microbiology or molecular biology.

Experience and Skills Required

• A minimum of 2 years experience in an equivalent position in the industry or in an academic environment;
• Knowledge and experience with  multi-parametric flow cytometry techniques and its generic applications in the field of IM including testing design as well as handling complex data set of multi-color panels;
• Knowledge of modern immunology and kept abreast with current literature, IM methodologies and clinical trial design and regulations;
• Knowledge of cell-based assays to monitor adaptive and innate immune responses;
• Experience working with FlowJo, Pestle, Spice, Prism and Excel
• Knowledge and understanding of GLP regulations and other regulatory guidelines sufficient to carry out GLP studies;
• Experience in project management;
• Experience with client management;
• Strong communication ability;
• Approaches work methodically and systematically;
• Establishes priorities from among a number of demands;
• Demonstrates and applies advanced level of understanding and analytical skills to interpret data and draw conclusions within the project goals;
• Critical and creative thinker;
• Communicates clearly and confidently and has excellent interpersonal skills;
• Skilled at working in a fast-paced and multi-tasking environment.

Position Summary

Leads method validation, assay transfer and sample analysis studies based on approved driving documents. Prepares and/or reviews experimental documentation for assigned studies. Prepares and/or fills associated documentation relevant to the studies as per appropriate SOP/CSP and applicable regulatory requirements. Writes and reviews method procedures (SOP/CSP). Responsible for binder submission to QA and answering of QA audit reports.

Responsabilities:

• Management of method validation, assay transfer and sample analysis studies;
• Prepares and/or reviews worksheets related to studies;
• Ensures personnel are trained and training appropriately documented;
• Ensures high level documents are signed and acknowledged by personnel involved in the study;
• Ensures study binders are up to date;
• Follows up on assigned study inventory and sample manifest;
• Follows up on deviations;
• Follows up on QC review and ensures it is performed in a timely fashion;
• Prepares and/or reviews of data tabulation and study related documents;
• Works in collaboration with the Principal Scientists, the Research Assistants and the Research Associates ; coordinates with the relevant transversal units (e.g. Data Analysis, QC, Sample Management, QA) to deliver quality data on time;
• Submits studies to QA and answers to QA reports;
• Schedules experiments based on the timelines, priorities and requirements;
• Writes and reviews method SOP/CSP;
• Responsible for coaching, mentoring, training and day to day interaction with the Research Assistants and the Research Associates for assigned studies;
• Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures.

The applicant must : 

• Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
• Employee is personally responsible for following Health and Safety guidelines/instructions.
• This position can involve evening and/or week-end work.

Profile:

• Master in Life Sciences or equivalent, preferably in Immunology.
• Experience level can vary, however, a minimum of 2 years of experience in similar position is required.
• Strong scientific knowledge;
• Good knowledge of clinical study conduct;
• Good knowledge and understanding of bioanalytical method validation guidelines and requirements;
• Knowledge and understanding of GLP, GCLP regulations to carry out GLP studies;
• Knowledge of procedures and protocols for containment of biohazardous material, safety procedures and guidelines.

Position Summary

Responsible for planning, organizing and overseeing the collection and shipping of biosamples to and from Caprion Biosciences S.A, to ensure timely delivery.

Responsibilities:

• Communicates with clinical sites, couriers and clients to track the delivery of study samples or study reagents on a daily basis;
• Verifies that sample collection information is adequate for effective sample tracking and reconciliation;
• Investigates and addresses discrepancies;
• Ensures issues are resolved or escalated in a timely manner;
• Tracks, reviews and updates the sample databases in a timely manner;
• Organizes international shipments as per IATA regulations to and from Caprion laboratory using the appropriate documentation;
• Participates in the writing and reviewing of Laboratory Manuals for clinical sites;
• Assists the operational staff for the procurement of biological samples from different suppliers;
• Assists the operational staff for the reception of biological samples;
• Ensures all work is compliant with appropriate SOPs and all applicable regulatory requirements;
• Defines and monitors Key Performance Indicators (KPI); 
• Participates in the writing and reviewing of SOPs and associated worksheets/forms;
• Applies Good Documentation Practices (GDP);

• Ensures all work is compliant with appropriate SOPs and all applicable regulatory requirements;
• Supervises and performs all biobanking-related activities (sample ordering, reception, documentation, tracking and inventory) in compliance with applicable procedures and according to the regulatory requirements.

The applicant must : 

• Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
• Employee is personally responsible for following Health and Safety guidelines/instructions.
• This position can involve evening and/or week-end work.

Profile:

• Bachelor degree in Logistics or related field
• Experience level can vary, however, a minimum of 2 years of experience in similar position is required.
• Basic knowledge of key aspects related to transportation of biosamples, such as import/export regulation, customs, sample handling, logistical planning;
• Knowledge of GCP, GCLP, and GLP regulations;
• Good communication skills and is fluent in French and English (written and spoken).

Position Summary:

Performs quality control activities relevant to her field of expertise. Reviews study experimental documentation and data based on appropriate driving documents, SOP/CSP following GLP regulations and GCLP guidelines. Review procedures (SOP/CSP).

Responsabilities:

• Perform QC review on experimental paperwork in timely fashion.
• Review data (tables, forms, calculations, etc.) and reports, as assigned;
• Review data tabulation and study related documents;
• Report findings to immediate supervisor to identify root cause and improvement opportunities;
• Help in implanting good quality control practices;
• Prepare the documentation to be transferred to the archives at study finalization; 
• Review SOP/CSP;
• Complete tasks in compliance with GLPs, driving documents and current procedures;
• Work in collaboration with the Principal Scientists and Research Assistants to deliver quality data on time
• Applies and train personnel on Good Documentation Practices (GDP);
• Train personnel on QC review, as needed.
• Performs biobanking-related activities (sample reception, tracking and inventory) in compliance with applicable procedures.

The applicant must : 

• Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
• Employee is personally responsible for following Health and Safety guidelines/instructions.
• This position can involve evening and/or week-end work.

Profile:

• B.Sc. or M.Sc. in Life Sciences
• Experience level can vary, however, a minimum of 2 years of industry experience in a similar position is required.
• Thorough knowledge of GLP and GCLP regulations;
• Basic knowledge in biochemistry and immunology;
• Knowledge of Microsoft Office programs, specifically Word and Excel;
• Knowledge of GCP, GCLP, ISO/IEC 17025 and GMP regulations;
• Excellent spoken and written communication skills in English and French.

Caprion HistoGeneX is currently recruiting a motivated HR Manager. You will be responsible for developing and implementing the HR initiatives in alignment with the strategic objectives of the organization.

You will be responsible for all aspects of HR (recruitment and talent management, people engagement payroll & benefits, remuneration packages and  training and development,) and you provide HR support to our business leaders across two US sites (Fremont, California & Naperville, Illinois).

You report to the global VP, Human Resources, based in Montreal.

Your key responsibilities are:

• Full responsibility for Talent Acquisition and manage the entire recruitment and selection process and set-up of onboarding programs including:
• Meet with business leaders to discuss and establish staffing objectives
• Provide support to hiring managers for recruitment and during the decision-making process
• Manage and evaluate all HR sourcing channels to ensure effectiveness and conformity to recruitment policies and best practices
• Partner with the leadership team to develop KPI(s) to monitor employee engagement and retention and identify areas for improvement
• Design and implement HR procedures that comply with labor regulations
• Develop and monitor overall HR strategies, systems, tactics and procedures across the organization
• Foster employee relations and proactively respond to employee relations issues by identifying problems and suggesting solutions
• Develop compensation and benefit plans for US
• Assess training needs and monitor training and development plans
• Execute various HR projects
• Manage a performance appraisal system that drives high performance with business leaders
• Monitor and report HR metrics to management and provide decision support to the business leaders
• Key player in the ESG (environmental, social & governance) initiatives related to data privacy, employee and social engagement
• Support change programs in the organization and act as a change agent
• Support the Finance organization with payroll budgets
• Work with the leadership team on succession planning and people retention strategies.
• Nurture a positive working environment and drive employee engagement initiatives.

Profile requirements

• Bachelor’s degree or above in Human Resources Management or related field
• Five or more years of relevant human resources experience with an expertise in general human resources functions
• Strong communication skills including proficiency in English, working with foreign counterparts and at ease negotiating
• Strong Hands-on mentality
• Comfortable presenting information in large groups and facilitating workshops
• Can organize resources (people, funding, material, and support) to get things done and can multitask and prioritize
• Knowledge and experience in recruiting concepts, practices and procedures, preferably in a high-volume and fast-paced environment
• Good knowledge of employment law regulations in the United States
• Ability to gain industry knowledge and provide pro-active and responsive solutions to business needs
• Experience working closely with stakeholders on sensitive issues and demonstrates discretion and ability to handle confidential and private information appropriately
• Interpersonally savvy and can relate well to people inside and outside of the organization. Builds appropriate rapport and builds constructive and effective relationships
• Can effectively cope with change and shift gears comfortably

We offer an exciting and challenging position in a multinational environment where customer focus and innovation are key business values.

Function :

Reporting to the Laboratory Team Leader and working closely with Principal Scientists, the Research Assistant will work within a team focusing on the characterization of the cellular and of the humoral immune response. The main responsibilities will include the development and execution of flow cytometry assays, viral neutralization assays, foci forming unit assays, Luminex and ELISA assays.

Tasks include :

• Perform cellular assays, viral neutralization assays and other serological assays according to current standard operating procedures;
• Establishment and maintenance of cell cultures;
• Manage reagents inventories and orders;
• Participate to the writing and/or to the review of method SOP and worksheets;
• Participate to the technical management of the laboratory;
• Perform work according to internal quality standards, apply relevant Quality System procedures and participate to the continuous improvement of Quality documents;
• Attend relevant internal training activities.

Profile of the applicant :

The applicant must hold a bachelor degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology. One or two years of demonstrated experience in techniques related to cellular and humoral immunology is preferred. 

The applicant must :

• Demonstrate excellent organisational skills.
• Demonstrate schedule adaptability and flexibility.
• Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes.
• Be willing to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP).
• Be functional in French (spoken and written) and have a functional knowledge of written English.  Knowledge spoken English is an asset.

Offer :

• Full time permanent contract, with possibility of rapid start.
• Diversified tasks and responsibilities.
• A professional, dynamic and stimulating work environment.
• Training and development opportunities.
• A competitive salary package including benefits, adapted to your experience and the context.

Interested?

Please, send your CV along with a short introduction letter. Additional information may be obtained by calling 071/96.23.36.

Your application and any information will be treated confidentially.

Fonction :

Se rapportant au Chef d’Equipe du Laboratoire et travaillant en étroite collaboration avec les Scientifiques Principaux, l’Assistant(e) de Recherche travaillera avec une équipe se concentrant sur la caractérisation de la réponse immunitaire cellulaire et humorale. Les principales responsabilités incluront le développement et l’exécution de tests de cytométrie en flux, de neutralisation virale, des tests du type « Luminex » et des ELISA.

Les tâches incluent :

• Effectuer des essais cellulaires, des tests de neutralisation virale et d’autres tests sérologiques en accord avec les procédures opérationnelles standardisées ;
• Établir et maintenir des cultures cellulaires ;
• Gérer les inventaires de réactifs et les commandes ;
• Participer à l’écriture et/ou à la révision de SOP et de feuilles de travail ;
• Participer à la gestion technique du laboratoire ;
• Effectuer le travail en accord avec les standards de qualité internes, appliquer les procédures pertinentes du Système Qualité et participer à l’amélioration continue des documents Qualité ;
• Participer aux activités de formation internes pertinentes.

Profil du/de la candidat(e):

Le/la candidat(e) doit posséder un bachelier (ou équivalent) en sciences de la vie tel que biologie, biologie médicale ou biochimie/biotechnologie. Une expérience d’un an ou deux en techniques relatives à l’immunologie cellulaire et humorale est souhaitée.

Le/la candidat(e) doit :

• Démontrer d’excellentes capacités organisationnelles ;
• Démontrer une adaptabilité et flexibilité au niveau de l’horaire ; 
• Vouloir participer activement à la génération, à l’implémentation et à l’amélioration continue des processus du laboratoire ;
• Vouloir travailler dans un environnement Qualité (ISO17025, GCLP, GMP) et appliquer les bonnes procédures de documentation (GDP) ;
• Avoir une connaissance fonctionnelle du français parlé et écrit et de l’anglais écrit. La connaissance de l’anglais parlé est un atout.

Offre :

• Un contrat temps plein à durée indéterminée, avec possibilité de démarrage rapide.
• Diverses tâches et responsabilités.
• Un environnement de travail professionnel, dynamique et stimulant.
• Des opportunités de formation et de développement.
• Un package salarial attractif incluant des avantages extra-légaux adapté à votre expérience et au contexte. 

Intéressé(e) ?

Faites parvenir votre CV ainsi qu’une courte lettre de motivation adaptée. Tout renseignement complémentaire peut également être obtenu au 071/96.23.36.

Votre candidature et informations associées seront traitées de manière confidentielle.