Sr. Manager/Associate Director, Stability Management

Role Summary

The Sr. Manager/Associate Director, Stability serves as the strategic and operational lead for all outsourced stability programs. This role oversees the design, execution, and evaluation of stability studies for both drug substance and drug product across early development, late-stage, and commercial programs.

Key Responsibilities

• Lead the strategic direction, planning, and governance of stability programs in alignment with ICH guidelines and regulatory requirements.

• Oversee the design, execution, monitoring, and management of development, registration, and commercial stability studies.

• Compile and interpret stability data, perform trend and statistical analyses, and prepare reports supporting shelf-life/retest extensions and storage condition recommendations.

• Serve as the primary liaison with contract organizations for all stability-related activities.

• Author and support CMC stability sections for IND, NDA, IMPD, Annual Reports, and other regulatory submissions, ensuring accuracy and completeness of stability data.

• Work cross-functionally with drug substance, drug product, supply chain, sourcing, and related teams to ensure alignment on stability strategy and study execution.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 10+ years of industry experience; or MS with 12+ years, or BS with 15+ years.

• 10+ years of experience in stability management with small molecules within the pharmaceutical or biotech industry.

• Experience with small-molecule oncology drug development.

• Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.).

• Extensive experience managing contract organizations and working in a virtual development model.

• Excellent leadership, people/team management, project management, and cross-functional collaboration skills.