Associate Director of QC Bioassay Lead

THE ROLE

• Develop and lead a world-class Bioassay team QC team, including planning, recruiting, coaching, and training. This role will enable you to shape and enhance our team’s capabilities.
• Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment.
• Prepare, review, and approve technical documents such as method protocols and validation reports.
• Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities.
• Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs.
• Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency.
• Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs.
• Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures.

• BSc or MSc in Biology/Cell Biology, Biochemistry/Molecular Biology, Immunology, Virology or related field.
• Strong understanding of analytical an
• Minimum of 5- 8 years of vaccine industry experience preferred, or minimum 5 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing.
• Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.
• Proven track record working cross-functionally across a wide variety of technical, business, and operational areas. Required Skills: Analytical Method Development, Cell Cultures, Deviations, GMP Compliance, Laboratory Management, People Management, Potency Assays, Quality Control (QC), Vaccine Manufacturing, Virology Preferred Skills: Biosafety, Vaccine Safety.

Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.