Associate Director, Stability Management

Summary / Job Purpose

The Associate Director, Stability Management is responsible for the establishment and management of the stability group within Exelixis CMC department. This role oversees the overall strategy and oversight of Exelixis’ stability and reference standard programs for drug substance, drug product and reference standard for both the commercial and clinical programs. Additional responsibilities include establishing Exelixis stability policies, procedures, and performance metrics internally and externally with CMOs.

The role provides oversight over the CMOs’ execution of the stability studies, authoring of the stability protocols, interim stability reports, and final stability reports. This role requires strong personnel resource management, communications, technical writing, and statistical analysis skills.

• Establish Exelixis stability policies and procedures.
• Establish and manage performance metrics.
• Oversee direct reports from the stability group.
• Manage activities related to drug substance and drug product stability testing, both commercial and clinical.
• Write and review stability protocols according to International Conference on Harmonization (ICH) guidelines.
• Manage and monitor contract laboratory stability testing to ensure adherence to the stability schedule outlined in the stability protocols.
• Review stability data (including raw test data), trend and track stability data, and determine drug product shelf life/retest date according to ICH guidelines.
• Investigate out‑of‑trend or out‑of‑specification results according to industry best practices.
• Manage, chair and present in regularly scheduled stability committee meetings.
• Write final stability reports for completed stability studies.
• Review and assess temperature excursions during storage and/or during transportation.
• Generate certificate of analysis and retest memos, setting and justifying specifications for both release and stability testing, and regulatory document controls.

• Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, and recommending salary increases, promotions, transfers, demotions, or terminations.
• Provide direction to other individuals.

• BS/BA degree in a related discipline and a minimum of eleven (11) years of related experience.
• MS/MA degree in a related discipline and a minimum of nine (9) years of related experience.
• PhD degree in a related discipline and a minimum of five (5) years of related experience.
• Equivalent combination of education and experience.

• GMP experience preferred.
• Technical laboratory experience in small molecules and solid oral dosage preferred.
• Experience in the pharmaceutical industry preferred.

• Extensive experience in relevant industry/profession and area of specialization.
• Ability to use professional concepts and company objectives to resolve complex issues creatively and effectively.
• Skill in identifying and implementing methods and procedures to achieve results.
• Capability to perform a variety of complicated tasks with a wide degree of creativity and latitude.
• Comprehensive understanding and wide application of technical principles, theories, concepts, and techniques.
• Good general knowledge of other related disciplines.
• Strong analytical and business communication skills.

• Primarily working indoors in an office environment.
• Travel required – 10% of time.

Our compensation reflects the cost of labor across several U.S. geographic markets. The base pay range for this position is $172,000–$244,000 annually, adjusted for geographic region, job‑related knowledge, skills, experience, and internal equity. In addition to the base salary, Exelixis offers a comprehensive employee benefits package, including a 401(k) plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales‑based incentive plan. Exelixis also…