Manager CMC Lipid and Raw Material | Chemiker (m/w/d)
BioNTech SE
Job Summary
This role involves acting as the CMC representative for raw materials, including lipids, excipients, and buffer solutions, within BioNTech's mRNA product pipeline. The successful candidate will ensure phase-appropriate GMP quality and coordinate material development, guiding new customized materials from preclinical R&D to commercial production at CDMOs. Key responsibilities include supervising CDMOs on process and analytical development, defining material requirements for suppliers, and evaluating risks to product quality and safety. The position requires leading supplier selection, compiling regulatory documents, and collaborating with various internal teams to identify material needs. It's an attractive opportunity for a professional with a strong background in chemistry or material science, offering a chance to make strategic decisions in a dynamic pharmaceutical environment.
Required Skills
Education
PhD in Chemistry, Pharmacy, or Material Science
Experience
- Several years of professional experience in an international pharmaceutical environment
- Profound knowledge of organic chemistry and material-related analytics
- Knowledge of GMP regulations
- Experience in working in a CMC development function, ideally with focus on material qualification or process validation
- Familiarity with regulatory filings for starting materials, novel excipients or APIs (IND/IMPD, BLA/MAA) is beneficial
Languages
Additional
- Not specified
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