Associate Director of QC Bioassay Lead
CareerWise Recruitment View all jobs
- Louth
- €90,000-120,000 per year
- Permanent
- Full-time
- 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.
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