Associate Director, Stability Management

Description

TSP is conducting a search for one of our clients, a leading biotechnology company focused on developing and commercializing cancer therapies to address high unmet medical needs and improve patients' lives.

As a result of the company's expansion of its Pharmaceutical Development and Manufacturing department, our client is seeking a talented and motivated Associate
Director of Stability Management, Analytical Development, and Quality Control.

Candidates must reside in the Bay Area or be open to relocating there. This is an on-site role and requires you to be in the office 3 days a week. Must have small-molecule stability experience.

Role

Summary:

The 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. The director is a self-driven contributor who partners cross-functionally and ensures that all stability activities meet ICH, cGMP, and global regulatory expectations.

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 organization and working in a virtual development model.
• Excellent leadership, people/team management, project management, and cross-functional collaboration skills.

TSP Talent Solutions and our customers are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)