A pharmaceutical professional with over twenty-five years of diverse global pharmaceutical, chemical industry, and medical devices experience from QA/QC, AR&D Labs to CRO/CDMO Project Management. I have in-depth knowledge of analytical chemistry in pharmaceutical R&D covering both small and large-molecule projects. Industry expert in cGMP, GLP, DEA, ICH guidelines, FDA, EMEA, ISO guidelines, and 21 CFR part 11 and 820 requirements. Expertise in drug development and clinical cGMP compliance. Strong analytical skills in HPLC, GC, TLC, UV, IR and wet chemical techniques. Thorough understanding of Setup//Startup, Operations, and Processes Development. Superb ability to research, analyze, and articulate complex data clearly and concisely.