About me
Mashuddin Jaigirdar is a retired pharmaceutical scientist with over 35 years of global experience in formulation development, process technology transfer, and manufacturing for brand and generic pharmaceuticals. He served as a Senior Quality Reviewer at the U.S. FDA, contributing to the review of DMFs, INDs, NDAs, and ANDAs for over 10 years. Recognized for his exemplary service, he received a Certificate of Appreciation from the FDA in 2020 and a Leadership Excellence Award in 2016. His expertise spans solid oral dosage forms, semi-solids, liquids, injectables, and ophthalmic preparations. Before joining the FDA, he held senior positions at Mylan, Actavis (Watson), and Aventis, specializing in Modified Release Technology and Paragraph IV ANDAs. Mash began his career in the 1970s at E.R. Squibb & Sons in Bangladesh and later worked in Sweden and Kuwait, leading process validation and technology transfer projects. He was widely respected as a mentor and trainer, formally training approximately 65 new FDA chemists. His contributions to Quality by Design (QbD) and risk assessment significantly impacted the FDA’s review processes. Mash’s legacy combines scientific excellence, regulatory insight, and dedication to knowledge sharing.
