Director of Manufacturing Sciences & Technology | Chemical engineer (m/w/d)
BioNTech SE
Job Summary
This strategic leadership role focuses on the technical lifecycle management of BioNTech's late-stage and commercial RNA and antibody-based therapeutics. The Director MS&T acts as the technical voice of the product, ensuring regulatory compliance and driving operational excellence from Process Performance Qualification (PPQ) through launch, lifecycle management, and discontinuation. Key responsibilities include leading the Commercial CMC Team, overseeing late-stage technical transfer, managing Biologics License Application (BLA) readiness, and handling post-approval change management plans (PACMP). The role requires an advanced degree in a relevant scientific or engineering discipline and extensive experience in CMC leadership, strategic partnerships, and GMP manufacturing investigations, making it ideal for a highly experienced professional seeking to drive technical strategy for commercial biopharma products.
Required Skills
Education
Advanced degree (Master’s or Ph.D.) in Biotechnology, Biochemistry, Chemical Engineering, or a related field.
Experience
- Extensive experience in late-stage product development, commercial manufacturing, and technical lifecycle management
- Proven track record in CMC leadership, including technical transfer, regulatory submissions, and post-approval change management
- Experience managing strategic partnerships with global collaborators (e.g., Pfizer, BMS)
- Professional experience leading cross-functional teams and managing complex technical projects
Languages
Additional
- Not specified
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