Helaas is deze vacature inmiddels waarschijnlijk verlopen
Analytical Project Manager
An exciting new opportunity as an
Analytical Project Manager (APM)
has become available with one of our
top Biopharma clients in Leiden, NL!
You will be part of the Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. 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. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, and virus neutralization assays.
Responsibilities:
- Ensure the timely and correct sample analysis of clinical samples, either in house or outsourced to CRO's or partners.
- Responsible for the technical and scientific evaluation and selction of candidate partners and for monitoring the outsourced activities.
- In house, the APM is responsible for the design, coordination and execution of assay development and validation, and for the organisation of the clinical sample analysis.
- These responsibilities must be executed, documented, and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.
Your profile:
- HLO/Master in Biological/Medical Sciences
- Knowledge of immunological assay development and validation
- Experience in clinical development of vaccines
- Communicative skills, fluent in English
- Basic management skills
- Trained in GLP, GCLP or GMP is an advantage, but training is provided in house
- Quality minded, flexible, able to take initiative and is a team player
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