Overview In this role, you will lead the stability group within Exelixis' CMC department to manage stability and reference standard programs for drug substance, drug product, and references for commercial and clinical programs. You will shape stability policies, oversee CMOs, and ensure high-quality stability data and reports. You'll drive cross-functional collaboration with regulatory, QA, and manufacturing to maintain compliant stability programs. This is a strategic, impact-focused role at scale in a fast-moving biotech environment.
Compensation / Benefits- 401k plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- discretionary annual bonus program
- stock purchase plan
Responsibilities- Establish stability policies and procedures
- Manage performance metrics and oversee stability group staff
- Oversee stability testing for drug substance and drug product (commercial and clinical)
- Author and review stability protocols per ICH guidelines
- Monitor contract laboratories for stability testing and adherence to protocols
- Review raw data and trend stability data to determine shelf life/retest dates per ICH
- Investigate out-of-trend/out-of-spec results per industry best practices
- Lead stability committee meetings and present findings
- Write final stability reports and assess temperature excursions
- Generate COA and retest memos and controls for regulatory documentation
Key requirements- GMP experience preferred
- Technical laboratory experience in small molecules and solid oral dosage preferred
- Pharmaceutical industry experience preferred
- BS/BA, MS/MA, or PhD with progressive years of experience as specified
- Strong analytical and business communication skills
- Ability to resolve complex issues creatively using professional concepts
- strong leadership and people management
- effective written and verbal communication
- analytical thinking and problem solving
- ICH guidelines
- stability protocol development and review
- data trend analysis and interpretation
