Govardhan Boga

Background

About Govardhan Boga

Analytical scientist with over 14 years of industrial experience in analytical R&D department. Team Handling, Sound knowledge of basic principles and operation of various analytical instruments such as HPLC/UPLC/SEC/FPLC, GC/GC-HS, FT-IR, UV/Visible spectrophotometer, Karl Fischer titrator, Auto titrator etc. Expertise in analytical method development and validation of raw materials, intermediates and final API's as per the ICH guidelines. Expertise in evaluation, identification and method development of Genotoxic impurities (GTI's) with method validation of the same by HPLC and GC. Alternate vendor development of API projects. Sound knowledge of impurity profiling and fate/purge, impurity profiling & carryover study of impurities from KSM's, intermediates and final API. Experience in finalization of the specification for RM, intermediates and final API. Cross functional interaction across all the manufacturing site/unit for method transfer activity of ongoing projects for successful execution of the same. Possess strong exposure in ELN (Electronic Lab Notebook) in ARD and releasing of the analytical results through ELN. Experience in investigation of the failure, plant issues related to analytical techniques, OOS etc. Well versed in Force degradation study of drug substances and identification of the degradation impurities with the help of LCMS technique. Experience in characterization of RM, Intermediates, final API and related impurities of API projects. Review and approve all the day today analytical activity to R&D and respective cross functional team. Plan and schedule maintenance and calibration activity of different instruments. Review calibration activity of the different instruments pertaining to the group. Experience in reviewing of protocol and validation reports of related substances, assay and residual solvents. Well verse with GLP, GDP and laboratory safety requirement as per the company policies.