Over 25 years of practical experience of Organic synthesis, such as non-infringing process development of API for regulated & non-regulated market,CRO and CRAMS industries. Development of cost competitive, feasible, environment friendly, less time consuming synthetic routes. Validation and scale up and technology transfer of targeted API and intermediates.Extensive experience in process optimization, process validation and developing new methodologies for non-infringing processes. Expertise in transferring the process from lab scale to commercialization in plant and well acquainted with ICH guidelines.The major goal is to develop cost efficient, non-infringing process of API for various therapeutic segments.Experience in area of crystallization, separations, purifications,& Identification of impurities using analytical tools such as NMR, GC & LC-MS, GC, HPLC and other sophisticated equipment.Preparation of developments reports, technical process packages, design of experiments by understanding the process parameters, process competitiveness,monthly reports and presentation of regular and ongoing research.• Purified several organic compounds from milligram to gram scale via normal phase/preparative/reverse phase/ flash column chromatography, recrystallization and fractional distillations using high vacuum technique• Structurally identified and characterized several compounds using NMR, U.V-Vis, GC-MS, HPLC, LC-MS, DSC, TGA, KF.Expertise: Organic process chemistry, Analytical chemistry, GLP and chemical process validation, scale up and technology transfer.
Listed skills include Technology Transfer, Hplc, Pharmaceutical Industry, Gmp, and 23 others.