Stability Management Lead, CMC

Exelixis, Inc.; Alameda (CA); On-site; USD 172,000 - 244,000; Full time

Benefits offered by this job

401k plan with company contributions

Medical, dental, and vision coverage

Discretionary annual bonus program

Stock purchase opportunities

15 accrued vacation days in the first year

Job summary

Exelixis, Inc. in Alameda, California seeks an Associate Director of Stability Management to lead the stability group within the CMC department. This role manages the stability and reference standard programs for both commercial and clinical products, ensuring compliance with ICH standards.

Key responsibilities include oversight of stability studies, managing performance metrics, and writing protocols and reports. Ideal candidates will have a strong educational background and extensive experience in stability management within the pharmaceutical industry.

Qualifications

• 11+ years of related experience with a BS/BA, 9+ years with MS/MA, or 5+ years with PhD.
• GMP experience preferred.
• Pharmaceutical industry experience preferred.

Responsibilities

• Establish Exelixis stability policies and procedures.
• Manage contract laboratory stability testing.
• Write and review final stability reports.

Skills

Personnel resource management

Communications

Technical writing

Statistical analysis

Education

BS/BA in a related discipline

MS/MA in a related discipline

PhD in a related discipline

Job description

Exelixis, Inc. in Alameda, California seeks an Associate Director of Stability Management to lead the stability group within the CMC department. This role manages the stability and reference standard programs for both commercial and clinical products, ensuring compliance with ICH standards.

Key responsibilities include oversight of stability studies, managing performance metrics, and writing protocols and reports. Ideal candidates will have a strong educational background and extensive experience in stability management within the pharmaceutical industry.