Associate Director, Analytical Transfer Lead | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This Associate Director role focuses on leading critical analytical technology transfer projects across the company's internal and external manufacturing and testing network, serving as the primary point of contact (SPoC) for Contract Manufacturing and Testing Organizations (CMOs/CTOs). The role involves defining communication strategies, ensuring compliance and harmonization of analytical testing, and overseeing the successful onboarding of new partners. Day-to-day tasks include leading transfer projects, conducting analytical investigations, troubleshooting routine production issues, and managing essential documentation (validation, work instructions). The ideal candidate holds a university degree in life sciences (e.g., Pharmacy, Chemistry, Biotechnology) and possesses several years of experience in a regulated pharmaceutical or biotechnology setting, specifically leading analytical transfers, method validation, and optimization under GMP standards. Expertise in the analytics of therapeutic proteins (like HPLC, bioassays, and ELISAs) is essential for success in this high-impact, fast-paced environment.
Required Skills
Education
University degree (Bachelor's or Master's) in Biology, Chemistry, Pharmacy, Biotechnology, or comparable Life Science or Healthcare field.
Experience
- Several years of working experience in a regulated Biotechnology or Pharmaceutical environment (ideally GMP)
- Professional experience leading analytical transfers, including method implementation, optimization, troubleshooting, and validation (ideally in QC)
- Professional experience with standard quality processes (OOS, deviations, Change control, CAPAs)
- Experience managing analytical and QC aspects at external partners (CMOs) (Desirable)
Languages
Additional
- Knowledge of relevant US, EU, EMA, and FDA regulatory standards (Desirable).
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