Head of Quality Control and Analytical Science and Technology | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This is a visionary leadership role requiring a seasoned professional to lead and develop the Analytical Science & Technology (AS&T) and Quality Control (QC) departments at a major manufacturing site in Marburg. The successful candidate will be responsible for building and continuously improving analytical methods and quality control systems, ensuring product quality throughout the production lifecycle. Day-to-day responsibilities include supervising routine testing, monitoring and approving deviations and CAPAs, and ensuring strict compliance with global regulatory standards, including cGMP, ICH, FDA, and EMA. The role requires fostering a culture of scientific and operational excellence while serving as the primary point of contact for regulatory inspections and audits. This position is critical for optimizing the efficiency of clinical and commercial production pipelines, securing the high standards of pharmaceutical manufacturing.
Required Skills
Education
Degree in natural sciences, pharmacy, engineering, or a related field
Experience
- 10+ years in developing, validating, and transferring analytical methods specific to biotech and clinical manufacturing
- Proven track record of successfully navigating regulatory inspections (e.g., FDA, EMA, PAI)
- Proven experience in effectively managing CMC-QC portfolios of multiple late-stage clinical products
- Extensive experience managing multidisciplinary teams in a high-stakes, fast-paced environment
Languages
Additional
- Delegated Responsibilities per §12 AMWHV (German Ordinance on the Manufacturing of Medicinal Products and Active Substances)
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