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Senior Manager

$164k - $205k

Revolution Medicines

Senior Manager, Commercial Manufacturing, Drug SubstanceRevolution 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-term strategic alignment.Communicate effectively with cross-functional project teams and senior leadership by providing clear technical, operational, and strategic updates.Travel domestically and internationally to CDMO and supplier sites to oversee technology transfer, validation, and commercial manufacturing activities (up to approximately 25%).Required Skills, Experience and Education:Bachelor's degree in Chemical Engineering, Chemistry or a related scientific discipline with a minimum of 8-10 years of relevant industry experience.Extensive experience in small molecule drug substance development, technology transfer, process validation, and commercial manufacturing within the pharmaceutical or biotechnology industry.Demonstrated expertise in late-stage development, commercial process validation, commercial manufacturing, Continued Process Verification (CPV), lifecycle management, and manufacturing scale-up/capacity expansion activities.Deep understanding of GMP manufacturing, regulatory expectations, and commercialization requirements for drug substance manufacturing.Proven experience managing CDMOs and external manufacturing networks in support of clinical and commercial supply.Demonstrated ability to lead complex cross-functional initiatives in fast-paced development environments.Strong leadership, communication, organizational, and problem-solving skills with the ability to influence across technical and business functions.Preferred Skills:Strategic and execution-oriented leader with strong technical depth and business acumen.Ability to balance scientific rigor, operational execution, and organizational priorities in a dynamic environment.Collaborative leadership style with demonstrated success building and developing high-performing teams and external partnerships.Strong sense of ownership, accountability, and commitment to operational excellence and patient impact.Base Pay Salary Range$164,000 - $205,000 USD

Vacancy posted 5 days ago
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