Director, Stability Management, Analytical Development and Quality Control

Opportunity

Playing a critical role as the stability program lead, the position will be responsible for overseeing and managing outsourced stability studies conducted. The director, stability is a self-motivated individual who works as a member of an integrated team contracting, designing, managing, and evaluating stability studies at contractors for both drug substance and drug product.

Required Skills, Experience and Education

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years, or BS with 18+ years.
• 10+ years in stability management or relevant experience within pharmaceutical or biotech industry.
• 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.
• Strong problem-solving skills with strategic and technically sound decision-making ability.
• Excellent written and verbal communication skills and interpersonal skills.
• Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.

Preferred Skills

• Experience with small molecule oncology drug development.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $211,000 - $264,000 USD.