Associate Director, Stability Management
Exelixis
August 30, 2026
On-site
Alameda, CA
Operations
Summary/Job Purpose:
The Associate Director, Stability Management is responsible for establishing and managing the Stability Group within Exelixis’ CMC department. Oversees stability and reference standard programs for drug substance, drug product, and reference standards for both commercial and clinical programs. Establishes stability policies, procedures, and performance metrics internally and with CMOs. Provides oversight of CMO execution of stability studies, including authoring stability protocols, interim stability reports, and final stability reports.
Essential Duties and Responsibilities:
- Establish stability policies and procedures.
- Establish and manage performance metrics.
- Oversee direct reports from the stability group.
- Write and review stability protocols per ICH guidelines.
- Manage/monitor contract laboratory stability testing per protocol schedules.
- Review stability data (including raw data).
- Trend and track data to determine shelf life/retest dates per ICH.
- Investigate out-of-trend and out-of-specification results using industry best practices.
- Manage, chair, and present at stability committee meetings.
- Author final stability reports for completed studies.
- Review/assess temperature excursions during storage and/or transportation.
- Generate certificates of analysis and retest memos; set/justify release and stability specs; ensure regulatory document controls.
Supervisory Responsibilities:
- Supervise staff (hiring, scheduling, work assignment, performance review; recommend HR actions).
- Provide direction to others.
Education/Experience (Required):
- BS/BA (11+ years) OR MS/MA (9+ years) OR PhD (5+ years) OR equivalent education/experience.
Preferred Qualifications:
- GMP experience.
- Technical laboratory experience in small molecules and solid oral dosage.
- Pharmaceutical industry experience.
Skills/Requirements:
- Extensive industry/professional experience in area of specialization.
- Ability to resolve complex issues; implement methods/procedures; strong analytical and business communication skills.
Travel/Working Conditions:
- Primarily indoor office work; ~10% travel.
The Associate Director, Stability Management is responsible for establishing and managing the Stability Group within Exelixis’ CMC department. Oversees stability and reference standard programs for drug substance, drug product, and reference standards for both commercial and clinical programs. Establishes stability policies, procedures, and performance metrics internally and with CMOs. Provides oversight of CMO execution of stability studies, including authoring stability protocols, interim stability reports, and final stability reports.
Essential Duties and Responsibilities:
- Establish stability policies and procedures.
- Establish and manage performance metrics.
- Oversee direct reports from the stability group.
- Write and review stability protocols per ICH guidelines.
- Manage/monitor contract laboratory stability testing per protocol schedules.
- Review stability data (including raw data).
- Trend and track data to determine shelf life/retest dates per ICH.
- Investigate out-of-trend and out-of-specification results using industry best practices.
- Manage, chair, and present at stability committee meetings.
- Author final stability reports for completed studies.
- Review/assess temperature excursions during storage and/or transportation.
- Generate certificates of analysis and retest memos; set/justify release and stability specs; ensure regulatory document controls.
Supervisory Responsibilities:
- Supervise staff (hiring, scheduling, work assignment, performance review; recommend HR actions).
- Provide direction to others.
Education/Experience (Required):
- BS/BA (11+ years) OR MS/MA (9+ years) OR PhD (5+ years) OR equivalent education/experience.
Preferred Qualifications:
- GMP experience.
- Technical laboratory experience in small molecules and solid oral dosage.
- Pharmaceutical industry experience.
Skills/Requirements:
- Extensive industry/professional experience in area of specialization.
- Ability to resolve complex issues; implement methods/procedures; strong analytical and business communication skills.
Travel/Working Conditions:
- Primarily indoor office work; ~10% travel.