Mainz, Germany | full time | Job ID: 10540
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.
Key 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 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.
Requirements
* 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 RNA and 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.
Preferred Qualifications
* 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 Benefits:
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 10540 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.