Temporary Stability Specialist
Temporary Stability Specialist
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
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.
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 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.
• BS/BA degree in Biology, Chemistry or related Sciences and five years of related experience; or,
• MS/MA degree in Biology, Chemistry or related Sciences and three years of related experience; or,
• Equivalent combination of education and experience.
• Experience working in a Quality Control work environment coordinating and monitoring stability studies.
• Experience in the pharmaceutical industry is preferred.
• Experience reviewing 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.
• 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 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.).