Director, Protein and ADC Analytics | Chemiker (m/w/d)
BioNTech SE
Job Summary
This Director role leads CMC project teams, focusing on the development and manufacturing of protein-based therapeutics and Antibody Drug Conjugates (ADCs), with a critical technical specialization in linker-payload analytics. The incumbent provides strategic and scientific input, establishes analytical development and control strategies, and ensures compliance with GMP standards and regulatory expectations. Day-to-day activities involve acting as the analytical Subject Matter Expert (SME) for regulatory filings (including authoring CTD Module 3 sections), overseeing analytical method development, validation, and transfer, and conducting complex problem-solving during technology transfer and routine production. Key qualifications include a Ph.D. or Master's in Analytical Chemistry and over 10 years of experience in a highly regulated international environment, coupled with strong expertise in techniques like HPLC, MS, and NMR. This position offers the opportunity to drive cutting-edge analytical strategies for novel drug development within an international setting.
Required Skills
Education
Master’s degree or preferably Ph.D. in Analytical Chemistry or a related field
Experience
- At least 10 years in an international, highly regulated environment
- Strong expertise in small molecule and ADC drug linkers analytical chemistry
- Proven experience in authoring CTD module 3 drug substance sections for regulatory submissions and filings
- Experience working in intercultural and cross-functional teams
Languages
Additional
- Not specified
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