Associate Director, Analytical Transfer Lead (AS&T Manufacturing Network) | Life Scientist (m/w/d)
BioNTech SE
Job Summary
This Associate Director role, serving as the Analytical Transfer Lead within the Analytical Sciences and Technology (AS&T) team, is crucial for advancing the product pipeline by managing analytical transfers across the internal and external manufacturing network. The successful candidate will act as the primary point of contact (SPoC) for analytical transfers involving Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). Day-to-day responsibilities include leading technology transfer projects, ensuring compliance and harmonization of analytical testing strategies, and overseeing the creation and approval of critical documentation, such as validation reports and work instructions. This position requires several years of experience in a regulated pharmaceutical or biotechnology environment, ideally under GMP, coupled with expertise in analytical methods for therapeutic proteins (e.g., HPLC, bioassays). This is an attractive opportunity for a highly organized, detail-oriented professional to drive continuous improvement and maintain state-of-the-art analytical methods in a fast-paced environment.
Required Skills
Education
University degree (Bachelor's or equivalent) in Biology, Chemistry, Pharmacy, Biotechnology, or comparable Life Science field; or an advanced degree in Life Science or Healthcare.
Experience
- Several years of professional experience in a regulated Biotechnology or Pharmaceutical environment (ideally GMP)
- Experience in leading analytical transfers, including method implementation, optimization, troubleshooting, and validation
- Professional experience in quality processes (OOS, deviations, Change control, CAPAs)
- Experience managing analytical/Quality Control aspects with external partners (CMOs) (Desirable)
Languages
Additional
- Knowledge of relevant US, EU, EMA, and FDA regulatory standards (Desirable).
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