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The companyOur client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands. Their Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. Hereto, the department executes the immunological strategy supporting the clinical development, and ensures the development, and validation of the required immunological assays, as well as the clinical sample analysis.
Role descriptionThe main responsibility of the Analytical Project Manager is to ensure the timely and correct sample analysis of clinical samples, either in house or outsourced to CRO’s or partners. You are responsible for the technical and scientific evaluation and selection of candidate partners for outsourcing, and for monitoring the outsourced activities. For in house activities the scientist is responsible for the design, coordination and execution of assay development and validation, and for the organization of the clinical sample analysis.
This role is full time only and entails no hands-on lab work. You will be offered a 1-year contract with the possibility of extension.
Responsibilities- Evaluating and selecting potential outsource partners;
- Monitoring outsourced analyses;
- Designing and coordinating assay development;
- Organizing clinical sample analyses
- Documenting and reporting all activities according to Good Clinical Laboratory Practice (GCLP) requirements.
RequirementsThe right candidate is quality minded, flexible, shows initiative and is a team player.
- HLO/Master in biological/medical sciences and several publications in immunology (no PhD)
- Minimal 3 years working experience in the clinical development of vaccines;
- Knowledge of immunological assay development and validation.
Other informationTrained in GCLP and/or GLP is a strong plus. The successful hire will be trained in these procedures in-house.