Senior Manager, Stability Management, Analytical Development and Quality Control

Revolution Medicines•Redwood City, CA

4h•$164,000 - $205,000•Hybrid

About The Position

Revolution Medicines is seeking a Senior Manager to serve as the subject matter expert in stability management and manage outsourced stability studies. The role works as part of an integrated team to design, manage, and evaluate studies conducted by contract organizations, supporting commercial and early- and late-stage clinical development. The position requires a strong understanding of ICH and cGMP guidelines and contributes to global regulatory filings related to stability. The Senior Manager coordinates stability activities, monitors schedules, manages data entry and review, and prepares presentations and reports. The role maintains the stability database, authors or reviews stability documents, analyzes study results and trends, and supports recommendations for retest or shelf-life extensions and storage conditions. It also coordinates samples and chain of custody, partners with Quality on quality events and investigations, and supports CMC stability documentation for IND, NDA, AR, and IMPD filings.

Requirements

PhD in Chemistry, Pharmaceutical Sciences, or a related discipline with 8 or more years of industry experience; or a master's degree with 10 or more years; or a bachelor's degree with 12 or more years.
Six or more years of stability management or relevant experience in the pharmaceutical or biotechnology industry.
Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations, including FDA and EMA.
Extensive experience managing contract organizations and working in a virtual development model.
Excellent leadership, people/team management, project management, and cross-functional collaboration skills.
Strong problem-solving skills and the ability to make strategic, technically sound decisions.
Excellent written and verbal communication and interpersonal skills.
Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.

Nice To Haves

Experience with small molecule oncology drug development.

Responsibilities

Coordinate stability activities, including monitoring schedules, data entry and review, and preparation of presentations and reports.
Track stability studies and maintain the stability database.
Author and/or review stability-related protocols, reports, and memos.
Work cross-functionally with CMC, Quality, Regulatory, Clinical, and related teams to achieve stability objectives.
Compile stability study results, perform trend and statistical analyses, and prepare reports supporting retest or shelf-life extensions and storage-condition recommendations.
Partner with Quality during stability quality events or investigations and support implementation of corrective and preventive actions at contract organizations.
Manage sample shipment, inventory tracking, and chain of custody for stability studies.
Support and author CMC stability documentation for IND, NDA, AR, and IMPD filings across clinical development and commercial activities, ensuring stability data completeness and accuracy.