Head of Quality Control & Analytical Science and Technology | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This leadership role involves overseeing the Analytical Science & Technology (AS&T) and Quality Control (QC) departments at a manufacturing site in Marburg, Germany. The successful candidate will be responsible for building and continuously improving analytical methods and quality control systems to ensure product quality throughout production, while maintaining compliance with all regulatory and cGMP requirements. Key responsibilities include strategic leadership of multidisciplinary teams, supervising routine testing, managing deviations and CAPAs, ensuring robust data integrity, and preparing for regulatory inspections. The role demands strong technical expertise in analytical challenges for complex molecules and proven experience in method development and validation within a cGMP-regulated biotech environment, fostering a culture of collaboration and innovation.
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, including incoming goods, finished product, and stability studies
- Expertise in quality management systems, with a focus on method validation, data integrity, and compliance
- Extensive experience managing multidisciplinary teams in a high-stakes, fast-paced environment
Languages
Additional
- Not specified
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