Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a project leading role and Subject Matter Expert (SME) of late phase and commercial Quality Control within the CMC function, this position will be responsible for overseeing a team and individually contributing to the management of QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP), and final product (FP) manufacturing. The candidate will also be responsible for post-approval QC activities including lifecycle management regulatory submissions such as CBE, PAS, etc.
Provide strategic and tactical ownership for QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, including establishment of CDMO and/or CTL.
End-to-end process management for analytical purposes in support of manufacturing operations for the release of commercial products.
Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs) for release and stability purposes.
Manage quality events related to commercial QC testing such as lab investigations (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0), and CAPAs.
Support regulatory submissions and lifecycle management to maintain operational compliance.
Collaborate with cross-functional teams including CMC RA, DS, DP, Supply Chain, and Quality Assurance to achieve project goals within timelines.
Required Skills, Experience, and Education:
BS or MS in Chemistry, Pharmaceutical Science, or related discipline.
10+ years of relevant industrial experience in analytical development/QC.
Solid understanding of compliance and regulatory requirements related to data integrity, process validation, manufacturing sampling and testing, stability studies, method validation, and transfer.
Effective written and verbal communication skills and interpersonal skills.
Extensive knowledge of cGMP guidelines and practices, as well as related industry best practices.
Strong problem-solving skills with sound technically driven decision-making ability.
Excellent communication skills (verbal, written, and technical), strong interpersonal and collaboration skills, and planning skills.
Ability to think critically and creatively, work independently, and determine appropriate resources for problem resolution.
Ability to multi-task and thrive in a fast-paced, innovative environment.
Preferred Skills:
Experience in solid oral dosage forms, including dissolution testing.
Knowledge and work experience with global regulatory submissions (IND, IMPD, NDA, MAA, etc.) is preferred.
Experience in Commercial QC.
Chromatographic experience in development, optimization, and troubleshooting.
The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed is intended for onsite workers in Redwood City and will be adjusted based on the candidate's location. Salary ranges are determined by role, level, and location, with individual pay influenced by skills, experience, market conditions, and education.
Please note that base salary is part of the overall rewards package, which includes competitive cash compensation, equity awards, benefits, and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, medical condition, or veteran status.
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