The Director Manufacturing Sciences & Technology role at BioNTech involves managing the technical lifecycle of late-stage and commercial products, ensuring compliance, innovation, and operational excellence. The successful candidate will be responsible for leading the Commercial CMC Team, driving technical transfer and Biologics License Application (BLA) readiness, and managing Post-Approval Change Management Plans (PACMP).
Requirements
- Act as the technical voice of the product, ensuring compliance with regulatory dossiers and advocating for technical excellence.
- Develop and execute strategies for the technical lifecycle management of late-stage and commercial products, including RNA and antibody-based therapeutics.
- Lead the Commercial CMC Team, ensuring alignment with BioNTech’s business objectives and regulatory requirements.
- Drive late-stage technical transfer and Biologics License Application (BLA) readiness, ensuring seamless execution and compliance.
- Oversee Responses to Questions (RTQs), launch support, GMP manufacturing investigations, process monitoring, and Annual Product Reviews (APRs).
- Manage Post-Approval Change Management Plans (PACMP) to ensure product compliance and continuous improvement.
- Identify and mitigate product risks while driving technical improvements across the product lifecycle.
- Serve as a matrix product lead, providing guidance, training, and communication to MS&T staff.
- Build and maintain strategic alliances with key partners, including Pfizer, BMS, and other collaborators.
- Act as the primary interface for strategic partnerships, ensuring alignment and collaboration on technical and regulatory objectives.
- Support product manufacturing by ensuring robust control strategies and compliance with regulatory standards.
- Lead investigations into GMP manufacturing issues, driving resolution and continuous improvement.
- Monitor and analyze product performance, ensuring alignment with quality and regulatory expectations.
Benefits
- Flexible hours
- Vacation account
- Digital Learning
- Performance & talent development
- Leadership development
- Apprenticeships
- LinkedIn Learning
- Your voice at the table
- Culture on an equal footing
- Opportunities to shape & impact
- Support for your full potential
- Company bike
- Job ticket
- Deutschlandticket
- Employer-funded pension
- Childcare
