Location: Redwood City,CA, USA
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's 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 critical role as the subject matter expert (SME) on Quality Control (QC) within Analytical Development and Quality Control - PDM, the position will be mainly responsible for managing QC activities from process validation to commercial manufacturing of drug substance (DS), drug product (DP), and final product (FP), maintaining cGMP-compliant quality control operations and documentation in support of Revolution Medicines pipeline compound development and clinical programs.
Responsibilities:
* Coordinate and manage outsourced QC activities (e.g., method transfer) of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs).
* Manage quality events related to analytical testing such as lab investigation, deviations, change controls, CAPAs.
* Author and / or review QC related documents, including method, protocol, report, and memos.
* Manage reference materials including monitoring retest date, facilitating qualification/requalification, tracking inventory.
* Provide support to quality systems (e.g., Veeva), documentation (e.g., SOP), and preparation for inspection as needed.
* Collaborate with cross functional teams including CMC Regulatory, DS, DP, Supply Chain, and Quality Assurance to timely achieve project goals.
Education, Experience and Skills Requirement:
* BS or MS in Chemistry, Pharmaceutical Science or related discipline.
* 6+ years of relevant industrial experience in analytical development/QC.
* Solid understanding of regulatory requirements as applicable to data integrity, analytical testing, stability study, method validation and transfer, etc, in small molecule drug development
* 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.
* Effective 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 Skills:
* Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.).
* QC with Commercial QC experience.
The base salary range for this full-time position is $120,000 to $148,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
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