Pradeep Kumar

Experience

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  Bharat Biotech International Limited

  Apr 2018 - Apr 2022

  Junior Executive

  Was responsible for routine testing of live, attenuated oral vaccines of Rotavirus and Poliomyelitis virus, Inactivated Japnese encephalitis and SARS-CoV-2 virusMajor highlight includes development of a cell based assay (FFU, PFU, IFU and TCID50) and SNT for Chimpanzee Adeno virus vector based SARS CoV-2 and Fluorescent antibody test for SARS CoV-2. Also developed S1 ELISA for vaccines against Coronavirus. Handled clinical trail samples for Covaxin and Jenvac. Performed inhibition ELISA for SARS CoV-2.Gained expertise in designing and carrying out different types of ELISA.Responsible for the method validation in drug substance and drug products to ensure the method performance at different attributes.Trained subordinates in order to create a second line for various tests. Imparted training to peers and subordinates on GXP. Lead a team of analysts in Rotavirus division in Quality control Virology. Was responsible for stability study execution and report prepration as per regulatory guidelines.Acquainted with FDA, ICH and WHO guidelines. Experienced in facing audits of WHO and CDSCO. Also faced regulatory audits of various countries. Show less

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  Panacea Biotec

  Jul 2022 - Dec 2023

  Senior Executive
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  Biological E. Limited

  Dec 2023 - now

  Assistant Manager

  Analytical Research and development