Manager, Quality Control, PDM

Revolution Medicines•Redwood City, CA

23h•Onsite

About The Position

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: 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. Manage 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.

Requirements

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.

Nice To Haves

Commercial QC experience is preferred.
Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.

Responsibilities

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.
Manage 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.