• Manage release testing and stability programs for various projects in commercial, preclinical and clinical development internally or at external parties. • Author, review, and approve stability protocols; responsible for planning, execution, data management, data analysis, and data trending to support drug substance (API)/drug product retest period/shelf-life determination. • Manage reference material program. • Review raw data to support release testing, stability testing, and reference materials qualification. • Manage, report, and trend stability data. • Escalate trends and support associated investigations, including temperature excursion assessment, client and regulatory requests. • Own and support stability-related deviations, investigations, CAPAs, and change controls. • Work in close collaboration and support with other members of the Technical Operations team responsible for API and DP development and provide support to management as necessary. • Support regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers), specifically stability and reference material sections. • Recommend updates and participate in authoring/reviewing of the department related Standard Operating Procedures and guidelines. • Maintain QC SOPs, methods, specifications, and other associated documents. • Review analytical methods, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMP and company standards. • Support QA on quality system and compliance activities, including audit functions. • Stay current on industry trends, practices, and regulatory guidelines. • Present stability updates to various internal audience.