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Revolution Medicines · 2 days ago
Associate Director, Analytical Development & Quality Control
Redwood City, CA
Full-time
Onsite
Director
$160K/yr - $200K/yr
10+ years exp
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Responsibilities
Manage QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP) and final product (FP) manufacturing.
Provide supports to stability program management, quality systems and QC documentation (e.g. SOPs) and PAI readiness and inspection as needed.
Lead and/or coordinate QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, in-process control test and final release test.
Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs).
Manage quality events related to commercial 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 commercial QC related documents, including methods, protocols, reports and memos.
Manage commercial phase 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
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Required
BS or MS in Chemistry, Pharmaceutical Science or related discipline.
10+ years of relevant industrial experience in analytical development/QC with 5+ years Commercial QC experience.
Solid understanding of relevant global and regional regulatory guidelines (FDA, EU, and ICH, etc.) as applicable to QbD, commercial process validation, commercial product launch, commercial manufacture sampling and testing, and post-approval quality control requirements.
Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
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.
Preferred
Effective written and verbal communication skills and interpersonal skills.
Excellent scientific and business 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.
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.
51-200 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
Trends of Total Sponsorships
2023 (14)
2022 (7)
2021 (2)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.25BKey Investors
Boxer CapitalNextech InvestThird Rock Ventures
2023-03-02Post Ipo Equity· $323.6M
2022-07-19Post Ipo Equity· $264.5M
2021-02-03Post Ipo Equity· $260.9M
Leadership Team
Mark A. Goldsmith
Founding President & Chief Executive Officer
Luan M. Wilfong
Chief Human Resources Officer
Recent News
Investor's Business Daily
2024-06-04
2024-05-19
Company data provided by crunchbase
