RAMESH V M

Designed & Synthesized API and Intermediate Investigation and Identification of known & unknown impurities for API R&D , Formulation R&D, Plant sample and Global project for regulatory requirements. Stability study for API (Drug substance) and Formulation sample (Drug product) Designed and synthesized Nitrosamine impurities for Drug substance, Drug product and regulatory requirements. Risk assessment for Nitrosamine impurities. Investigation of OOS,OOT and OOE events. Extractable & Leachable study for Drug products. Synthesized 150+ impurities for API, Formulation, plant (production site) and Global queries.

Identification, Isolation, Characterization & Synthesis of process/degradation/Pharmacopeial impurities in new existing drug substances/products. Support plan QA/QC (API/Formulation) in the investigation of OOS/OOT events arising out of chemistry/process problem. To develop non-infringing, cost effective technologies for synthesis of impurities oncology/ non-oncology drugs. Creating technical documents (Report/result/BPCR). Complete synthesis of impurities, identification and characterization of them followed by making them as standards for future reference. Characterization/Spectral data from LC-MS/NMR/MS/IR/UV etc. Sound knowledge of chemistry, parents and regulatory affairs

Research and Development in Discovery Chemistry at Syngene international limited Medicinal chemistry, Small molecule synthesis and Custom synthesis. FTE Chemist: Nikem, Medivir, Merck serono, Merck KGaA, TOLOROFORM,ITEOS with electronic laboratory note book updates daily basis.

Chemoinformatics at Jubilant Biosys