Associate Director, Stability Management
Exelixis
June 28, 2026
Remote friendly (Alameda, CA)
United States
Operations
Associate Director, Stability Management (CMC)
Summary/Job Purpose
- Establish and manage the Stability group within the CMC department. Oversee Exelixis stability and reference standard programs for drug substance, drug product, and reference standards across commercial and clinical programs. Create stability policies/procedures/metrics; oversee CMO execution of stability studies and reporting.
Responsibilities
- Establish Exelixis 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 lab stability testing to ensure adherence to the stability schedule.
- Review stability data (including raw data); trend and determine shelf life/retest dates per ICH.
- Investigate out-of-trend/out-of-spec results using industry best practices.
- Manage, chair, and present stability committee meetings.
- Author final stability reports.
- Review/assess temperature excursions during storage and/or transportation.
- Generate certificates of analysis and retest memos; set/justify release and stability specifications; manage regulatory document controls.
Supervisory Responsibilities
- Supervise staff (hiring, scheduling, work assignment, performance review; recommend personnel actions) and provide direction.
Qualifications/Experience
- BS/BA with 11+ years, or MS/MA with 9+ years, or PhD with 5+ years (related discipline), or equivalent.
- Preferred: GMP experience; technical lab experience in small molecules and solid oral dosage; pharmaceutical industry experience.
Skills
- Strong analytical and business communication skills; technical expertise in stability concepts/principles; ability to resolve complex issues and produce high-quality technical/statistical work.
Benefits (as stated)
- 401(k) with generous company contributions; medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus; 15 vacation days (year 1); 17 paid holidays (incl. December winter shutdown); up to 10 sick days.
Application Instruction
- For disability accommodations during application/recruitment: recruiting@exelixis.com
Summary/Job Purpose
- Establish and manage the Stability group within the CMC department. Oversee Exelixis stability and reference standard programs for drug substance, drug product, and reference standards across commercial and clinical programs. Create stability policies/procedures/metrics; oversee CMO execution of stability studies and reporting.
Responsibilities
- Establish Exelixis 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 lab stability testing to ensure adherence to the stability schedule.
- Review stability data (including raw data); trend and determine shelf life/retest dates per ICH.
- Investigate out-of-trend/out-of-spec results using industry best practices.
- Manage, chair, and present stability committee meetings.
- Author final stability reports.
- Review/assess temperature excursions during storage and/or transportation.
- Generate certificates of analysis and retest memos; set/justify release and stability specifications; manage regulatory document controls.
Supervisory Responsibilities
- Supervise staff (hiring, scheduling, work assignment, performance review; recommend personnel actions) and provide direction.
Qualifications/Experience
- BS/BA with 11+ years, or MS/MA with 9+ years, or PhD with 5+ years (related discipline), or equivalent.
- Preferred: GMP experience; technical lab experience in small molecules and solid oral dosage; pharmaceutical industry experience.
Skills
- Strong analytical and business communication skills; technical expertise in stability concepts/principles; ability to resolve complex issues and produce high-quality technical/statistical work.
Benefits (as stated)
- 401(k) with generous company contributions; medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus; 15 vacation days (year 1); 17 paid holidays (incl. December winter shutdown); up to 10 sick days.
Application Instruction
- For disability accommodations during application/recruitment: recruiting@exelixis.com