Associate Director CMC Manufacturing Technologies | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This temporary 18-month role as Associate Director of CMC Manufacturing Technologies in Mainz, Germany, involves overseeing phase-appropriate requirements for raw materials and excipients within a global CMC team. The successful candidate will be responsible for authoring and maintaining gap assessments, managing Quality by Design (QbD) documents like Critical Material Attributes (CMA) and Critical Quality Attributes (CQA) templates, and providing guidance to project-specific CMC teams. This position is ideal for an experienced professional with a strong background in the pharmaceutical or biotech industry, particularly in materials, who thrives in a fast-paced environment and possesses excellent communication skills to collaborate with internal and external stakeholders.
Required Skills
Education
Degree in a scientific or engineering field; advanced degree preferred.
Experience
- Minimum of 5 years in the pharmaceutical or biotech industry
- At least 3 years specializing in materials
- Professional experience in overseeing phase-appropriate requirements for raw materials and excipients
- Professional experience in developing and maintaining material-related QbD documents
- Professional experience in collaborating with internal and external teams for material compliance
- Professional experience in supporting CMC teams for material requirements, especially individualized RNA therapeutics
- Professional experience in driving continuous improvement for raw material assessment and procurement
Languages
Additional
- Temporary replacement for 18 months; cannot be offered on a permanent basis.
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