Specialist Manufacturing Processes Operations (Chemistry) | Chemiker (m/w/d)
BioNTech SE
Job Summary
This role supports the daily manufacturing operations at a facility producing individualized neoantigen-specific cancer therapeutics. The Specialist will act as a key support for Subject Matter Experts (SMEs), leveraging deep process knowledge across several critical areas including DNA and RNA production, lipoplexation, fill & finish, and packaging. Day-to-day responsibilities involve rigorous handling of process deviations, conducting root cause analysis, performing risk assessments, and defining Corrective and Preventive Actions (CAPA management). Furthermore, the specialist coordinates change control procedures within the production environment. The ideal candidate holds a university degree in a scientific or technical field and possesses at least two years of relevant manufacturing experience, preferably within a regulated biotech or pharmaceutical setting, combined with good knowledge of EU GMP regulations.
Required Skills
Education
University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area
Experience
- 2 years of experience in manufacturing/production or relevant experience
- Experience in a biotech or pharmaceutical company (ideal)
- Professional experience supporting subject matter experts (SMEs)
Languages
Additional
- Good knowledge of EU GMP regulations
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