Revolution Medicines · 1 month ago
Senior Manager, Analytical Development & QC
Redwood City, California, United States
Full-time
Onsite
Senior Level
$158K/yr - $198K/yr
6+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The Senior Manager will play a leading role in Quality Control, managing QC activities from process validation to commercial manufacture and ensuring compliance with regulatory requirements.
Health CareLife ScienceMedical
Responsibilities
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
Qualification
Required
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
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
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase