Head of Quality Control & Analytical Science and Technology | Ingenieur (m/w/d)
BioNTech SE
Job Summary
This leadership role seeks a visionary professional to head the Analytical Science & Technology (AS&T) and Quality Control (QC) departments at a biotechnology production 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 across all production phases, strictly adhering to regulatory and cGMP requirements. The position involves strategic leadership, overseeing routine testing, ensuring data integrity, leading regulatory inspections, and developing/validating analytical methods for clinical and commercial manufacturing. This role is ideal for someone passionate about fostering a culture of collaboration and innovation while optimizing efficiency in pharmaceutical production.
Required Skills
Education
Degree in Natural Sciences, Pharmacy, Engineering, or a related field
Experience
- 15+ years in the development, validation, and transfer of analytical methods, specifically for biotechnology and clinical manufacturing
- Proven track record in conducting and navigating regulatory inspections (e.g., FDA, EMA, PAI)
- Extensive experience in developing, optimizing, and implementing analytical methods in a cGMP-regulated biotechnology or clinical production environment
- Extensive experience in leading multidisciplinary teams in a demanding, dynamic environment
Languages
Additional
- Not specified
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