Associate Director, Stability Management
Exelixis
5 hours ago
Remote friendly (Alameda, CA)
United States
Operations
Summary/Job Purpose
The Associate Director, Stability Management is responsible for establishing and managing the stability group within Exelixis’ CMC department. Oversees the strategy and oversight of stability and reference standard programs for drug substance, drug product, and reference standards across commercial and clinical programs, including policies, procedures, and performance metrics with CMOs. Provides oversight of CMO stability execution and authoring/review of stability protocols, interim reports, and final reports.
Essential Duties and Responsibilities
- Establish Exelixis stability policies and procedures.
- Establish and manage performance metrics.
- Oversee direct reports from the stability group.
Drug Substance/Product Stability Testing (Commercial and Clinical)
- Write and review stability protocols per ICH guidelines.
- Manage and monitor contract laboratory stability testing to ensure protocol schedule adherence.
- Review stability data (including raw test data).
- Trend and track stability data to determine shelf life/retest dates per ICH guidelines.
- Investigate out-of-trend and out-of-specification results using industry best practices.
- Manage, chair, and present at regularly scheduled stability committee meetings.
- Write final stability reports.
- Review and assess temperature excursions during storage and/or transportation.
- Generate certificate of analysis and retest memos; set and justify release/stability specifications and regulatory document controls.
Supervisory Responsibilities
- Supervise staff (hiring, scheduling, work assignment, performance reviews; recommend salary increases, promotions, transfers, demotions, or terminations).
- Provide direction to others.
Education/Experience
- BS/BA (related discipline) + 11 years; or MS/MA + 9 years; or PhD + 5 years; or equivalent education/experience.
Experience/Preferred
- GMP experience (preferred).
- Technical laboratory experience with small molecules and solid oral dosage (preferred).
- Pharmaceutical industry experience (preferred).
Knowledge/Skills
- Extensive relevant industry/professional experience.
- Ability to resolve complex issues creatively and effectively.
- Strong analytical and business communication skills.
- Strong technical understanding and application of stability-related principles and methods.
Working Conditions
- Primarily office-based; ~10% travel.
Benefits
- Base pay range: $172,000–$244,000 annually.
- Comprehensive benefits (401k with company contributions, medical/dental/vision, life/disability, flexible spending), discretionary bonus/incentive (role-dependent), stock purchase, long-term incentives, 15 vacation days (year 1), 17 paid holidays (including winter shutdown), up to 10 sick days.
The Associate Director, Stability Management is responsible for establishing and managing the stability group within Exelixis’ CMC department. Oversees the strategy and oversight of stability and reference standard programs for drug substance, drug product, and reference standards across commercial and clinical programs, including policies, procedures, and performance metrics with CMOs. Provides oversight of CMO stability execution and authoring/review of stability protocols, interim reports, and final reports.
Essential Duties and Responsibilities
- Establish Exelixis stability policies and procedures.
- Establish and manage performance metrics.
- Oversee direct reports from the stability group.
Drug Substance/Product Stability Testing (Commercial and Clinical)
- Write and review stability protocols per ICH guidelines.
- Manage and monitor contract laboratory stability testing to ensure protocol schedule adherence.
- Review stability data (including raw test data).
- Trend and track stability data to determine shelf life/retest dates per ICH guidelines.
- Investigate out-of-trend and out-of-specification results using industry best practices.
- Manage, chair, and present at regularly scheduled stability committee meetings.
- Write final stability reports.
- Review and assess temperature excursions during storage and/or transportation.
- Generate certificate of analysis and retest memos; set and justify release/stability specifications and regulatory document controls.
Supervisory Responsibilities
- Supervise staff (hiring, scheduling, work assignment, performance reviews; recommend salary increases, promotions, transfers, demotions, or terminations).
- Provide direction to others.
Education/Experience
- BS/BA (related discipline) + 11 years; or MS/MA + 9 years; or PhD + 5 years; or equivalent education/experience.
Experience/Preferred
- GMP experience (preferred).
- Technical laboratory experience with small molecules and solid oral dosage (preferred).
- Pharmaceutical industry experience (preferred).
Knowledge/Skills
- Extensive relevant industry/professional experience.
- Ability to resolve complex issues creatively and effectively.
- Strong analytical and business communication skills.
- Strong technical understanding and application of stability-related principles and methods.
Working Conditions
- Primarily office-based; ~10% travel.
Benefits
- Base pay range: $172,000–$244,000 annually.
- Comprehensive benefits (401k with company contributions, medical/dental/vision, life/disability, flexible spending), discretionary bonus/incentive (role-dependent), stock purchase, long-term incentives, 15 vacation days (year 1), 17 paid holidays (including winter shutdown), up to 10 sick days.