Associate Director CMC Manufacturing Technologies | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This role is for an experienced Associate Director to join a global CMC team in Mainz, Germany, focusing on raw materials and excipients for individualized RNA therapeutics. The successful candidate will be responsible for overseeing phase-appropriate material requirements, authoring gap assessments, and managing Quality by Design (QbD) documents like Critical Material Attributes (CMA) and Critical Quality Attributes (CQA) templates. This position involves significant collaboration with internal and external teams to ensure compliance through all clinical phases, supporting CMC teams, and driving continuous process improvement for material assessment and procurement. The role is a temporary 18-month parental leave replacement, offering a chance to contribute to cutting-edge biopharmaceutical manufacturing.
Required Skills
Education
Degree in a scientific or engineering field; advanced degree preferred
Experience
- Minimum of 5 years of experience in the pharmaceutical or biotech industry
- At least 3 years specializing in materials
- Profound knowledge of GMP regulations and biopharmaceutical manufacturing requirements related to materials
- Expertise in QbD approaches with an emphasis on materials
Languages
Additional
- Temporary parental leave replacement for 18 months; not a permanent position.
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