Director Manufacturing Sciences & Technology (m/f/d)

Your Qualifications:

• 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 internal teams and external partners.
  
• Strong interpersonal skills and experience managing strategic partnerships with global collaborators (e.g., Pfizer, BMS).
  
• Analytical mindset with a proactive approach to identifying and mitigating risks.
  
• Experience with Biologics License Applications (BLA) and Responses to Questions (RTQs).
  
• Familiarity with Good Manufacturing Practices (GMP) and Annual Product Reviews (APRs).
  
• Expertise in managing Post-Approval Change Management Plans (PACMP).

Your Tasks:

• 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.

» Job description