Senior Manager Commercial Manufacturing Drug Substance positions focus on delivering results in their domain. This page aggregates open Senior Manager Commercial Manufacturing Drug Substance roles and what employers typically expect.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. Revolution Medicines is seeking an experienced and strategic leader to serve as Senior Manager, Commercial Manufacturing, Drug Substance within the PDM organization. This individual will play a critical role in advancing/supporting the company’s API commercial manufacturing by providing technical and operational oversight and/or support across late-stage development, process validation, commercial manufacturing and lifecycle management for small molecule drug substances. The successful candidate will support commercial drug substance manufacturing activities at external manufacturing partners as part of the Commercial Manufacturing group within the Drug Substance team. This role will provide support for technology transfer, supply strategy, process robustness initiatives, CPV and capacity planning while ensuring that our external partners continue to supply quality material on-time. This individual will work cross-functionally with Process Chemistry, Quality Control, Pharmaceutical Development, Quality Assurance, Regulatory, and Supply Chain teams and will serve as a key technical leader in ensuring reliable and compliant commercial manufacturing operations across Revolution Medicines’ drug substance portfolio. The Opportunity: Support and oversee commercial drug substance manufacturing activities for Revolution Medicines’ API portfolio, including Process Performance Qualification (PPQ), Continued Process Verification (CPV), lifecycle management, and capacity expansion activities aligned with commercial demand forecasts. Support the development and execution of manufacturing capacity strategies to support anticipated commercial demand. Assess manufacturing network capabilities and constraints and lead initiatives to expand throughput, improve operational efficiency, and ensure long-term commercial supply continuity. Proactively identify, assess, and mitigate manufacturing, supply, technical, quality, compliance, and business risks that may impact timelines, regulatory commitments, budget, capacity, or supply continuity. Ensure any process improvements align with the established robust process characterization and control strategies. Support identification, evaluation, selection, onboarding, and technical oversight of CDMOs and external manufacturing partners, including development of redundant supply strategies and geographic diversification to enhance supply chain resilience. Support and/or oversee technology transfer, process familiarization, engineering runs, validation campaigns, scale-up activities, and commercial manufacturing operations at external manufacturing sites. Write, review, and approve technical documents including protocols, batch records, development reports, validation reports, campaign summaries, investigations, and regulatory support documentation associated with commercial manufacturing. Partner cross-functionally with Process Chemistry, Quality, Regulatory, Supply Chain, and Pharmaceutical Development teams to support regulatory submissions, inspections, launch readiness, and ongoing commercial supply. Establish strong and collaborative relationships with CDMOs and suppliers to ensure operational excellence, technical rigor, execution reliability, and long-…