Quality Control Manager Bioassay

Algemene omschrijving

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;

The ideal candidate should have:

• Master or degree in life sciences, chemistry, biotechnology or equivalent.
• 8-10 years of proven experience in a Quality or related environment, of which 4 or more years in a leadership position.
• Experience in Quality Control.
• Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, etc.)
• General knowledge of the pharmaceutical industry and pharmaceutical research and development.
• Organizational planning and problem-solving experience.
• Strong leadership & development qualities.
• Experience with principles of Process Excellence, Lean manufacturing, etc is a pre.
• Good presentation skill
• Excellent knowledge of English
• Handling and leading a medium-large (40-60) size specialized group, (8-10 direct reports)
• Personal and interpersonal skills: informed decision making, digitalization and digitization, analytical thinking, Strong Quality Awareness and Flexible

• A salary range between 91 - 114K + 16% bonus target (based on education and working experience)
• An exciting position in an international and dynamic environment with continuous learning and growth opportunities;
• A competitive salary, on-site sport accommodations, health/energy programs and other benefits for you and your family;
• An inclusive team environment where diversity and different opinions are respected and valued, and the importance of a good work-life balance is recognized.

Are you interested or do you have questions? Please, do not hesitate and feel free to give me a call!

Gestelde eisen

Master or degree in life sciences, chemistry, biotechnology or equivalent. 8-10 years of proven experience in a Quality or related environment, of which 4 or more years in a leadership position.

Uren

32-40 hours

Salaris

€7000 - €9000 per maand