Over 25 years experience working primarily in the analytical space covering early stage through commercialization with extensive knowledge across vaccines, biologics, and gene therapy. Working in the GMP space has provided me with a strong background in all aspects of GMP encompassing QC release and stability; investigations including deviations, change control, and CAPAs; and regulatory/CMC support including inspections and filings. This work encompasses primarily large molecule therapeutics across vaccines, biologics and gene therapy. Blending practical experience in laboratory management, GMP principles, and regulatory guidances has made me uniquely qualified across multiple areas of laboratory compliance. Working cross-functionally both internally and externally has provided me with a valuable perspective on stability and the associated complexities.