Associate Director, Stability Management
Exelixis
August 09, 2026
On-site
Alameda, CA
Operations
Associate Director, Stability Management
Summary/Job Purpose
- Establish and manage the stability group within the Exelixis CMC department.
- Oversee strategy and oversight of stability and reference standard programs for drug substance, drug product, and reference standards for commercial and clinical programs.
- Establish stability policies, procedures, and performance metrics internally and with CMOs.
- Oversee CMO execution of stability studies, including stability protocols and interim/final stability reports.
Responsibilities
- Establish stability policies and procedures.
- Establish and manage performance metrics.
- Oversee direct reports from the stability group.
- Manage drug substance and drug product stability testing (commercial and clinical), including:
- Write and review stability protocols per ICH guidelines.
- Manage/monitor contract laboratory stability testing vs. protocol schedules.
- Review stability data (including raw data).
- Trend/track data to determine shelf life/retest dates per ICH.
- Investigate out-of-trend or out-of-specification results.
- Manage, chair, and present at stability committee meetings.
- Write final stability reports.
- Review temperature excursions during storage and/or transportation.
- Generate certificates of analysis and retest memos; set/justify release and stability specifications; manage regulatory document controls.
- Supervise staff (hiring, scheduling, work assignment, performance review, and personnel actions).
Qualifications/Required Experience
- BS/BA (11+ years) OR MS/MA (9+ years) OR PhD (5+ years) in a related discipline, or equivalent education/experience.
Preferred Qualifications
- GMP experience.
- Technical lab experience in small molecules and solid oral dosage.
- Pharmaceutical industry experience.
Skills
- Strong analytical skills; technical writing; statistical analysis; communications.
Application Instructions
- For disability accommodation related to application/recruitment: recruiting@exelixis.com.
Summary/Job Purpose
- Establish and manage the stability group within the Exelixis CMC department.
- Oversee strategy and oversight of stability and reference standard programs for drug substance, drug product, and reference standards for commercial and clinical programs.
- Establish stability policies, procedures, and performance metrics internally and with CMOs.
- Oversee CMO execution of stability studies, including stability protocols and interim/final stability reports.
Responsibilities
- Establish stability policies and procedures.
- Establish and manage performance metrics.
- Oversee direct reports from the stability group.
- Manage drug substance and drug product stability testing (commercial and clinical), including:
- Write and review stability protocols per ICH guidelines.
- Manage/monitor contract laboratory stability testing vs. protocol schedules.
- Review stability data (including raw data).
- Trend/track data to determine shelf life/retest dates per ICH.
- Investigate out-of-trend or out-of-specification results.
- Manage, chair, and present at stability committee meetings.
- Write final stability reports.
- Review temperature excursions during storage and/or transportation.
- Generate certificates of analysis and retest memos; set/justify release and stability specifications; manage regulatory document controls.
- Supervise staff (hiring, scheduling, work assignment, performance review, and personnel actions).
Qualifications/Required Experience
- BS/BA (11+ years) OR MS/MA (9+ years) OR PhD (5+ years) in a related discipline, or equivalent education/experience.
Preferred Qualifications
- GMP experience.
- Technical lab experience in small molecules and solid oral dosage.
- Pharmaceutical industry experience.
Skills
- Strong analytical skills; technical writing; statistical analysis; communications.
Application Instructions
- For disability accommodation related to application/recruitment: recruiting@exelixis.com.