Ph.D.(Medicinal Chemistry/ Organic Chemistry) with Post Doc and more than 13 years of diversified experience in Research & Development (including Steroids, Hormones, Hetero-cycle, Peptide based APIs and their Impurity Synthesis and characterization through HNMR, C13NMR, IR, MS) for Generic & NCE API for NI process and its DMF Filing.
Scale-up and Technology Transfer from lab scale to kilo lab, Pilot Plant and Plant Scale for commercial Production.
Generating Scientific Documents related to pre- and post- product development phases.
Review and response to queries from various regulatory agencies.
Practicing and Implementing GLP, GMP, QbD, PAT and SHE policies.
Generic R&D of low vol...