Quality Control Manager Bioassay (INCB20732) Leiden , Nederland
The QC Bioassay Laboratory is responsible for the release, stability testing of (semi) finished products (monoclonal antibodies and vaccines.) Leiden QC represents various combined test labs classified based on specific techniques and/or expertise.
You, as a QC Manager Bioassay, will lead with credo principles at hand ensuring the diversity and inclusion of the team shaping, simplifying and innovating the bioassay testing in close collaboration with Analytical Development colleagues. Your team is responsibel for the onboarding of several New Product Introduction (NPI'S) including transfer and validation of the CART/Lentivirus methods. The team consists of four specialties with their own expertise and experts: ELISA, Bioassay, Cell Culture and PCR/Lentivirus.
Other main responsibilities:
- Recruitment, hiring, onboarding and development of personnel;
- Running the budget of the group and provide inputs for the OPEX and CAPEX budget;
- Ensuring the overall complience to regulatory cGMP requirements, global standards, procedures;
- Ensuring (testing) activities are in line with the timelines, resources and budget;
- Escalating and investigation (lab/OOS/OOT) and assay performance issues;