Stability Programs Lead, Analytics & QC

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines, Inc. is seeking a Sr. Manager, Stability to lead outsourced stability studies and ensure GMP/ICH-compliant data for regulatory submissions. You will work with design, management, and evaluation teams across clinical development and commercial activities.

The role requires a PhD or equivalent clinical/pharma experience, strong leadership, and cross-functional collaboration in a fast-paced environment, onsite in Redwood City, CA.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences or related field with 8+ years of industry experience; MS with 10+ years; or BS with 12+ years.
• 6+ years in stability management or relevant experience in pharma/biotech.
• Strong knowledge of GMP, ICH guidelines, and regulatory expectations (FDA, EMA).
• Extensive experience managing contract organizations and virtual development models.
• Excellent leadership, project management, and cross-functional collaboration skills.
• Strong problem-solving with strategic and technical decision-making ability.
• Excellent written and verbal communication and interpersonal skills.
• Energetic, team-oriented, and adaptable to a fast-paced environment.

Responsibilities

• Coordinate stability activities: monitor schedule, data entry, reviews, and reports.
• Track stability studies and maintain the stability database.
• Author or review stability-related documents (protocols, reports, memos).
• Collaborate with CMC, quality, regulatory, clinical teams to meet stability objectives.
• Compile results, perform trend analyses, and support retest or shelf-life decisions.
• Partner with QA during stability events or CAPAs at CROs.
• Manage sample shipment and chain of custody for stability studies.
• Support CMC stability documentation for IND, NDA, AR and IMPD filings.

Skills

Stability management

Contract management

Regulatory knowledge (FDA/EMA)

Cross-functional collaboration

Leadership

Data analysis

Written and verbal communication

Education

PhD in Chemistry/Pharmaceutical Sciences

MS in related field

BS in related field

Tools

Stability database software

Job description

Revolution Medicines, Inc. is seeking a Sr. Manager, Stability to lead outsourced stability studies and ensure GMP/ICH-compliant data for regulatory submissions. You will work with design, management, and evaluation teams across clinical development and commercial activities.

The role requires a PhD or equivalent clinical/pharma experience, strong leadership, and cross-functional collaboration in a fast-paced environment, onsite in Redwood City, CA.