Scott Thatcher is a seasoned authority in the pharma/biopharma industry with over 20 years of comprehensive drug development expertise. Specializing in Chemistry, Manufacturing, and Controls (CMC) of corporate assets, Scott has delivered exceptional results for both Innovator and Contract Partner (CDMO) organizations. His proficiency in authoring IND/ANDA/NDA/BLA submissions in eCTD format has contributed to the successful market launches of numerous products, including Gemzar®, Xigris®, Cialis®, and more.
His CMC contributions are vast, including development and validation of hundreds of procedures for analytical/bioanalytical techniques as per ICH requirements, managing testing for ICH stability programs, and providing manufacturing operations support for process optimization/QbD, scale-up, and process validation. Scott has also demonstrated proven experience in Quality Management Systems (QMS), having initiated two systems from scratch at different CDMOs.
Scott is a published author in analytical chemistry and biological research, specializing in photostability studies in line with the ICH Q1B guideline. He earned his BSc. degree in Molecular Biology from Purdue University. His commitment to excellence and extensive industry knowledge make him an invaluable asset in the field of pharma/biopharma.