Senior Stability Manager – Analytical Dev & QC (Hybrid)

Revolution Medicines; Redwood City (CA); In loco; USD 164.000 - 205.000; Tempo pieno

Descrizione del lavoro

Revolution Medicines in Redwood City, CA seeks a Sr. Manager, Stability to lead outsourced stability studies and collaborate with CMC, QA, and regulatory teams to support filings across development programs.

The role requires advanced degree with extensive stability experience, GMP/ICH knowledge, and strong leadership to drive data integrity and timely decisions in a fast-paced biotech environment. This senior SME will oversee sample custody, data analysis, and collaboration with contract

Competenze

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 8+ years industry experience.
• 6+ years in stability management in pharma/biotech.
• Strong GMP, ICH knowledge and regulatory expectations (FDA, EMA).
• Extensive experience managing CROs and virtual development models.
• Excellent leadership and cross-functional collaboration skills.
• Strong written and verbal communication skills.
• Energetic, team-oriented and adaptable to a fast-paced environment.

Mansioni

• Coordinate stability activities: monitor schedule, data entry, review and reports.
• Track stability studies and maintain stability database.
• Author/review stability documents (protocols, reports, memos).
• Work cross-functionally with CMC, quality, regulatory, clinical teams.
• Compile stability results, perform trend analyses, support shelf-life/date extensions.
• Partner with QA during stability events and CAPA implementations.
• Manage sample shipment, inventory, and chain of custody for stability studies.
• Support CMC stability documentation for IND, NDA, AR and IMPD filings.

Conoscenze

Stability management

CRO/vendor management

Cross-functional collaboration

Leadership

Regulatory affairs knowledge

Communication

Problem solving

Formazione

PhD in Chemistry or related discipline

MS in Chemistry or related discipline

BS in related discipline

Descrizione del lavoro

Revolution Medicines in Redwood City, CA seeks a Sr. Manager, Stability to lead outsourced stability studies and collaborate with CMC, QA, and regulatory teams to support filings across development programs.

The role requires advanced degree with extensive stability experience, GMP/ICH knowledge, and strong leadership to drive data integrity and timely decisions in a fast-paced biotech environment. This senior SME will oversee sample custody, data analysis, and collaboration with contract