Associate Scientist
Current Involved in method development, method qualification as per ICH Q2R1 guidelines for monoclonal antibodies and therapeutics protein and related excipient and transfer of the method to respective departments. Hands on various chromatography detector like Evaporative light scattering detector (ELSD), Refractive index detector (RID), Charged aerosol detector (CAD), Fluorescence detector (FLD), Ultraviolet visible detector (UV), etc. Completed Analytical similarity and various characterization activity of monoclonal antibodies and therapeutics protein. Involved in the query response activity by various regulatory bodies. Planning, analysis and data review of various in process analysis, batch release and stability support to various early and late stage department.. Analysis with different non chromatography technique: UV, BET, Extractable volume, etc. Responsible for periodic maintenance and calibration of equipment and maintain the schedule according to defined SOP/Protocol. Preparation and review of SOP, MOA, STP, Protocols and equipment qualification document IQ, OQ and PQ according to required. Involved in Computer System Validation. Winner of Value ranger and Bravo award for great team player.
