Director Manufacturing Sciences & Technology

Mainz, Germany   |   full time   |   Job ID: 10540  About the role: BioNTech’s late-stage and commercial products require expert stewardship to manage the technical lifecycle, ensuring compliance, innovation, and operational excellence. As the  Director MS&T , you will be the technical voice of the product, advocating for regulatory compliance while bridging the gap between BioNTech’s business needs and technical execution. This strategic leadership role focuses on RNA and antibody commercial products, driving technical excellence from PPQ (Process Performance Qualification) through product launch, lifecycle management, and discontinuation. Your contribution: 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 antibody-based therapeutics. Acts as the accountable MS&T representative for the CMC interface and key point of contact for strategic partnerships, 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. A good match: Advanced degree (Master’s or Ph.D.) in Biotechnology, Biochemistry, Chemical Engineering, or a related field. 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. Deep understanding of antibody-based products, control strategies, and regulatory compliance. Demonstrated ability to lead cross-functional teams and manage complex technical projects. Excellent verbal and written communication skills, with the ability to effectively engage with…