Senior Manager, Analytical Development & QC

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.The Opportunity:Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of RevMed clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP), including managing stability programs, reference materials, and raw materials at contract organization. The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.Provide support for stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to in-process control test, final release test, and stability study.Manage quality events related to QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.Author and/or review QC related documents, including methods, protocols, reports and memos.Lead method validation/transfer activities at CDMOs and / or contract testing labs (CTLs)Manage reference standards and reference materials including monitoring retest date, facilitating qualification/requalification, and tracking inventory.Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to timely achieve project goals.Required Skills, Experience and Education:BS or MS in Chemistry, Pharmaceutical Science or related discipline.6+ years of relevant industrial experience in analytical development/QC.Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, QbD, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.Effective written and verbal communication skills and interpersonal skills.Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.Strong problem-solving skills with sound technically driven decision-making ability.Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.Ability to multi-task and thrive in a fast-paced innovative environment.Preferred Skills:Experience in solid oral dosage including dissolution testing.Commercial QC experience is preferred.Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.Chromatographic experience in development, optimization, and troubleshooting. #LI-Hybrid #LI-CT1The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact View email address on click.appcast.io Pay Salary Range$164,000—$205,000 USDWe are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to View email address on click.appcast.io so we can share these impersonations with our IT team for tracking and awareness.