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Sr. Manager / Associate Director, Drug Substance Development & Manufacturing / Hybrid
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- Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
- Responsibilities include oversight of late development/launch preparation activities including (but not limited to): the development of chemical processes for active pharmaceutical ingredients (APIs) and regulatory starting materials (RSMs), process scale-up, technology transfer, and validation of chemical processes.
- Ensure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch
- Lead scale-up, process development, process engineering, and finalization (validation) of process for commercial-scale manufacturing
- Extract scientific data and provide appropriate document review to support regulatory filings and commercialization in a timely manner
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