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CMC Operations, Director
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$205,000 - $225,000 a year
Full-time
- Reporting to VP of CMC Ops, the Director of CMC Operations is responsible for drug substance development and manufacturing in support of clinical development and commercialization of 89bio’s biologics pipeline drugs.
- Evaluate biologics-based processes for purity, cost, and yield optimization.
- Manage tech transfer, process familiarization, process development, GMP preparation and manufacturing activities of CDMOs∯*∯
- Develop and maintain adequate in-process analytical testing and controls in conjunction with CDMO and internal Analytical Development, Quality Control, and Regulatory.
- On-board and familiarize new Tech-Ops members on Process Development and Manufacturing activities for Drug Substance and Critical Enzyme Reagents
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