Senior Manager, Stability Management, Analytical Development and Quality Control

Revolution Medicines•Redwood City, CA

2d•Onsite

About The Position

Revolution Medicines is seeking a Senior Manager to serve as the subject matter expert on stability management and oversee outsourced stability studies. The role works as part of an integrated team to design, manage, and evaluate stability studies conducted by contract organizations, supporting commercial and early- through late-stage clinical development. The position requires knowledge of ICH and cGMP guidelines and the ability to contribute stability information to global regulatory filings. The Senior Manager coordinates stability activities, tracks studies and maintains the stability database, and authors or reviews stability protocols, reports, memos, and regulatory documentation. The role collaborates with CMC, quality, regulatory, clinical, and related teams; analyzes stability results and trends; and prepares reports supporting retest or shelf-life extensions and storage-condition recommendations. It also partners with quality on stability-related quality events, investigations, and CAPA implementation at contract organizations, and manages sample shipments, inventory, and chain of custody. The position supports CMC stability documentation for IND, NDA, AR, and IMPD filings, ensuring stability data are complete and accurate across clinical development and commercial activities. The role is based onsite at the company’s Redwood City, California headquarters; the posting also includes the hashtag #LI-Hybrid.

Requirements

PhD in Chemistry, Pharmaceutical Sciences, or a related discipline with 8 or more years of industry experience; or MS with 10 or more years; or BS with 12 or more years.
At least 6 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

Serve as the subject matter expert for stability management.
Manage outsourced stability studies and work with contract organizations to design, manage, and evaluate them.
Coordinate stability activities, including monitoring schedules, data entry, review, and presentations or reports.
Track stability studies and maintain the stability database.
Author and/or review stability-related documents, including protocols, reports, and memos.
Collaborate 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 on stability quality events and investigations, and on implementation of CAPAs 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, ensuring stability data are complete and accurate.