New

Stability Manager

Exelixis
paid holidays, sick time, 401(k)
United States, California, Alameda
Oct 25, 2025
SUMMARY/JOB PURPOSE: The Stability Manager responsible for supporting activities related to commercial and clinical drug substance and drug product stability studies at various contract laboratories. Areas of responsibility include but are not limited to monitor contract laboratory stability testing, prepare stability summaries and final stability reports, trend stability data and maintain stability database current, review of release/stability raw data. Essential Duties And Responsibilities: Monitor stability studies at various contract laboratories to ensure adherence to the stability schedules outlined in the stability protocols. Follow up with contract laboratories to obtain complete stability documentation and laboratory records within the established timelines. Perform technical review of release and stability data (including raw test data) to ensure compliance with all established and approved analytical procedures. Prepare stability summaries for ongoing stability studies and write final stability reports at the end of the stability studies. Track and trend stability data. Review results transcribed to data tables, protocols, and reports to ensure accuracy. Enter data and maintain stability database current. Maintain stability programs in compliance with regulatory requirements and commitments for clinical and commercial products. Prepare stability documentation for regulatory filings. Support analytical activities for the qualification of reference standards. Perform product impact assessment for temperature excursion events encountered during storage and shipment of commercial and clinical drug substance and drug product. Supervisory Responsibilities: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: BS/BA degree in Biology, Chemistry or related Sciences and a minimum of seven years of related experience; or, MS/MA degree in Biology, Chemistry or related Sciences and a minimum of five years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Experience working in a Quality Control work environment coordinating and monitoring release or stability studies. Experience in the pharmaceutical industry is preferred. Experience reviewing release or stability raw data and documents generated in an analytical test laboratory is preferred. Experience with stability management and tracking systems. Experience with trending stability data and performing statistical analyses. Technical hands-on laboratory experience in small molecules and solid oral dosage is preferred. Knowledge/Skills: Ability to monitor and trend stability data, maintain stability database current, and ensure compliance for multiple commercial and clinical drug substance and drug product stability programs at various contract laboratories. Proven ability to manage multiple assignments and effectively complete all expected deliverables in a timely manner. Knowledge of Good Manufacturing Practices and FDA/ICH/EMEA Guidelines as they apply to stability. Ability to communicate clearly and effectively, both verbally and in writing. Must have strong organizational skills and be detail oriented. Demonstrate ability to take initiative and work independently. Experience with Microsoft Office (Word, Excel, Power Point, etc.) #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $112,500 - $160,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.