Director, Drug Substance

Role: Lead process research and development within the Drug Substance function for Revolution Medicines' late-stage oncology pipeline, focusing on process design, optimization, and scale-up of RAS(ON) inhibitors. Responsibilities: develop and optimize chemical processes for drug substances and intermediates, ensure regulatory compliance through QbD principles and DOE studies, manage technology transfer to CDMOs, oversee CRO/CDMO relationships, author regulatory documentation, and collaborate across analytical, pharmaceutical, and supply chain teams. Requirements: PhD (or MSc with 10+ years) in organic chemistry or chemical engineering; 15+ years (MS) or 10+ years (PhD) industry experience in process R&D; expertise in synthetic organic chemistry, GMP, ICH guidelines, and regulatory submissions; proven project management with CROs/CDMOs; strong problem-solving, communication, and leadership skills. HighValue: experience with biologics manufacturing, regulatory filings (IND, IMPD, NDA), and working with CMC strategies in a clinical or commercial setting. WorkSetup: onsite in Redwood City, CA, with up to 15% travel for CRO/CDMO oversight.