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Associate Director, Drug Substance Manufacturing
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- Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate.
- The Associate Director, Drug Substance Manufacturing is responsible for supporting Sagimet’s drug substance activities, from early development through Phase 3 clinical supply to NDA registration activities and preparation for commercial manufacturing.
- In this role, you will provide synthetic and manufacturing technology expertise, drive process development/optimization, and lead technology transfers.
- Further, you will oversee drug substance clinical manufacturing, scale-up, registration batches, process validation, and commercial manufacturing preparedness.
- Draft relevant CMC sections of regulatory documents including INDs, IMPDs, NDAs, and MAAs.
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