Stability Manager

Role Summary

The Stability Manager is responsible for supporting activities related to commercial and clinical drug substance and drug product stability studies at various contract laboratories. Areas of responsibility include monitoring contract laboratory stability testing, preparing stability summaries and final stability reports, trending stability data, maintaining the stability database current, and reviewing release/stability raw data.

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.

Qualifications

• BS/BA degree in Biology, Chemistry or related Sciences with a minimum of seven years of related experience; or
• MS/MA degree in Biology, Chemistry or related Sciences with a minimum of five years of related experience; or
• Equivalent combination of education and experience.
• Experience working in a Quality Control environment coordinating and monitoring release or stability studies (preferred).
• Experience in the pharmaceutical industry (preferred).
• Experience reviewing release or stability raw data and documents generated in an analytical test laboratory (preferred).
• Experience with stability management and tracking systems (preferred).
• Experience with trending stability data and performing statistical analyses (preferred).
• Technical hands-on laboratory experience in small molecules and solid oral dosage (preferred).

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.
• Clear and effective verbal and written communication.
• Strong organizational skills and attention to detail.
• Ability to take initiative and work independently.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, etc.).

Education

• BS/BA in Biology, Chemistry or related Sciences; or
• MS/MA in Biology, Chemistry or related Sciences; or
• Equivalent combination of education and experience.