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 manufacturing technologies. The successful candidate will be a key CMC Material Expert, responsible for overseeing phase-appropriate requirements for raw materials and excipients. This involves developing and maintaining Quality by Design (QbD) documents, including Critical Material Attributes (CMA) and Critical Quality Attributes (CQA) templates, and conducting gap assessments. The role requires strong collaboration with internal and external teams to ensure compliance throughout clinical phases and supporting CMC teams with a focus on individualized RNA therapeutics. The position also involves driving continuous process improvement for material assessment and procurement. This is a temporary 18-month parental leave replacement.
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, particularly related to materials
- Expertise in QbD approaches with an emphasis on materials
- Professional experience working independently and prioritizing tasks in a fast-paced, dynamic environment
Languages
Additional
- Temporary parental leave replacement for 18 months
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