Senior Manager, Analytical Development & QC
$164k - $205kRevolution Medicines
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
- Effective written and verbal communication skills and interpersonal skills.
- Extensive knowledge and understanding of cGMP guidelines and practices, as
- Experience in solid oral dosage including dissolution testing.
- Commercial QC experience is preferred.
- Work experience and knowledge of global regulatory submissions (IND, IMPD,
- and Privacy Policy
- For additional information, please
$164,000—$205,000 USD
-------------------------------------------------------------------------------- We 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. --------------------------------------------------------------------------------- ...patients' lives. As a result of the company’s expansion of its Pharmaceutical Development and Manufacturing department, our client is seeking a talented and motivated Sr. Manager, QC & Analytical Development. Candidates must reside in the Bay Area or be open to...SeniorContract workWork at officeRelocation3 days per week
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