Director, Drug Substance
$211,000–$264,000 year
On-site · Redwood City, California, United States
Job Summary
Director, Drug Substance with technical leadership responsibility for process research and development and scale-up of manufacturing to support Revolution Medicines’ pipeline. Develop chemical processes for drug substance, intermediates, and starting materials, including route evaluation and process optimization. Conduct QbD-based process development to enable regulatory starting materials designation, establish control strategy, and perform process characterization using DOE. Lead/enable technology transfer and manufacturing at CDMOs; identify and manage CROs/CDMOs with emphasis on supply redundancy and geographic diversity. Draft and approve protocols, batch records, development and campaign reports; contribute to CMC sections of regulatory filings and patent applications. Collaborate with analytical development, pharmaceutical development, and supply chain to design program strategies. Communicate effectively within cross-functional teams. Travel to CRO/CDMO for oversight (up to ~15%). PhD (minimum MSc) in organic chemistry, chemical engineering or related discipline; 10+ years (15+ years for MSc) of industry experience in chemical/drug substance process R&D; strong people management and hands-on synthetic chemistry skills; knowledge of ICH, GMP, and regulatory submissions (IND/IMPD/NDA/MAA); experience managing CROs/CDMOs; strong problem solving and communication skills; innovative team-player. Base pay range: $211,000—$264,000.
Required Qualifications
- PhD (minimum MSc degree) in organic chemistry, chemical engineering or related discipline
- 10 or more years (15+ years for Master’s degree) of relevant industrial experience in chemical / drug substance process research and development
- Strong people management skills
- Hands-on proficiency in synthetic organic chemistry
- Knowledge of current ICH guidelines, GMP, and relevant industry practices
- Working experience and knowledge of regulatory submissions (IND, IMPD, NDA and MAA)
- Previous experience managing projects at CROs/CDMOs
- Strong problem solving skills with sound technically driven decision-making ability
- Effective written and verbal communication skills and interpersonal skills
- An innovative team-player with high energy for our dynamic company environment
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