Analytical Project Manager
For one of our clients in the Leiden area we are looking for an Analytical Project Manager (APM).
Department: The 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. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and virus neutralization assays.
The Analytical Project Manager (APM) main responsibility is to ensure the timely and correct sample analysis of clinical samples, either in house or outsourced to CRO’s or partners. For outsourcing, the APM is responsible for the technical and scientific evaluation and selection of candidate partners, 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. The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality.
Requirements for the function as a Analytical Project Manager:
- HLO/Master in biological/medical sciences and several publications in immunology (no PhD);
- Minimal 3 years working experience;
- Knowledge of immunological assay development and validation;
- Experience in clinical development of vaccines;
- Communicative skills;
- Fluency in English required, Dutch is highly advantaged;
- Basic management skills;
- Trained in GCLP and/or GLP is a strong plus. The successful hire will be trained in these procedures in-house.
Competences: The right candidate is quality minded, flexible, shows initiative and is a team player.
Must be strong on communication skills. Role entails no hands-on lab work, but the APM aligns with multiple people in department (with exposure also to external partners in US, attending teleconference calls). Role is strongly documentation/report writing focused, so we’re looking for a detail-focused and/or analytical minded individual, who enjoys working full time on procedures and guidelines, and associated communications to gather information.
This is a maternity leave cover for 1 year with long term perspective.
More info about this Analytical Project Manager position? Call or mail Leonie Koomen 06-10518323 or email@example.com