Director Manufacturing Sciences & Technology

Responsibilities

• 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 RNA and antibody-based therapeutics.
• Lead the Commercial CMC Team to ensure alignment with business objectives and regulatory requirements.
• Drive late-stage technical transfer and Biologics License Application (BLA) readiness.
• Oversee Responses to Questions (RTQs), launch support, GMP manufacturing investigations, and Annual Product Reviews (APRs).
• Manage Post-Approval Change Management Plans (PACMP) to ensure continuous product improvement.
• Build and maintain strategic alliances with key global partners such as Pfizer and BMS.
• Identify and mitigate product risks while ensuring robust control strategies and GMP compliance.

Requirements

• 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 and regulatory submissions.
• Deep understanding of RNA and antibody-based products and their control strategies.
• Experience with Biologics License Applications (BLA) and Responses to Questions (RTQs).
• Familiarity with Good Manufacturing Practices (GMP) and Annual Product Reviews (APRs).
• Strong interpersonal skills with experience managing strategic partnerships with global collaborators.

Benefits

• Flexible working hours and vacation accounts.
• Professional growth through digital learning, leadership development, and LinkedIn Learning.
• Health and lifestyle support including a company bike and job ticket (Deutschlandticket).
• Financial security through employer-funded pensions and childcare support.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, through advanced mRNA and antibody-based technologies.