Specialist Manufacturing Processes Operations | Biologe (m/w/d)
BioNTech SE
Job Summary
This crucial role supports the daily operations within a Pilot Facility dedicated to the individualized manufacturing of cancer therapeutics in Mainz. The Specialist will act as a subject matter expert (SME), providing deep process knowledge across key production areas including DNA/RNA manufacturing, Lipoplexation, Fill & Finish, labeling, packaging, and visual inspection. A core responsibility involves maintaining smooth production flow by handling process deviations, conducting root cause analysis and risk assessment, and defining necessary Corrective and Preventive Actions (CAPA). Furthermore, the role coordinates all Change Control processes within the production environment. Candidates must hold a university degree in a scientific or technical field (e.g., Biology, Chemistry, Engineering) and possess at least two years of relevant experience, ideally within a GMP-regulated Biotech or Pharmaceutical setting. This position offers the unique opportunity to contribute directly to life-saving personalized medicine while benefiting from flexible hours and a hybrid work model.
Required Skills
Education
University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or another technical/scientific field
Experience
- 2 years of experience in manufacturing/production or relevant industry experience
- Professional experience, ideally in a Biotech or Pharmaceutical company
Languages
Additional
- High diligence, accuracy, conscientiousness, and detail-orientation required
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