Associate Director, Stability Strategy & Oversight

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

Benefits offered by this job

401k plan

Medical/dental/vision coverage

Life insurance

Disability insurance

Stock purchase program

Discretionary annual bonus

Job summary

Exelixis is seeking an Associate Director of Stability Management to lead the stability group within the CMC organization. You will oversee stability programs for drug substance, drug product, and reference standards across commercial and clinical programs, while partnering with CMOs to ensure protocol adherence and data integrity.

The role requires strong leadership, technical writing, and statistical analysis skills, with responsibilities spanning policy development, performance metrics, and

Qualifications

• GMP experience preferred.
• Technical laboratory experience in small molecules and solid oral dosage forms preferred.
• Experience in the pharmaceutical industry preferred.

Responsibilities

• Establish stability policies and procedures.
• Oversee the stability program and metrics.
• Supervise stability group staff and performance reviews.
• Write/review stability protocols per ICH guidelines.
• Manage contract labs and review stability data.
• Generate stability reports and COAs.

Skills

GMP experience

Technical laboratory experience

Pharmaceutical industry experience

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Job description

Exelixis is seeking an Associate Director of Stability Management to lead the stability group within the CMC organization. You will oversee stability programs for drug substance, drug product, and reference standards across commercial and clinical programs, while partnering with CMOs to ensure protocol adherence and data integrity.

The role requires strong leadership, technical writing, and statistical analysis skills, with responsibilities spanning policy development, performance metrics, and