Nitin Sharma

Quality Control/ Bioassay & Immunoassay / Biosimilar & vaccine/ Cell Culture/ PCR/ ELISA/ QMS/Regulatory Affairs

Role
Executive at Biocon
Location
New Delhi, DL, IN
LinkedIn followers
500 followers
General Business & ManagementView LinkedIn profile

About Nitin Sharma

Quality Control, Quality Assurance, and Regulatory Affairs (CMC)-aligned pharmaceutical…

Experience

  1. Executive

    Biocon

    Apr 2024 — Present · Bengaluru, IN

    Handling and Maintaining of Cell Culture, Cell Lines, Revival, Subculture and Cryopreservation of cell lines( Adherent and Suspension).In-Vitro Cell Based IOP Assay for range of Monoclonal Antibodies(Trastuzumab, Pertuzumab, Itolizumab, Bevacizumab).Flow Cytometry based assay (HER 2 and Potency by Binding test). FC-gamma based Assay (Surface Plasmogen Resonance).Practical knowledge of evaluating Inprocess, DS and DP samples for LPA (ELISA ) as well as HCDNA qPCR methods.To perform Method validation and Method transfer.GDP-compliant documentation and review that adheres to ALCOA++

Education

  • Lovely Professional University

    Btech biotechnolgy

    2017 — 2021

  • Jamia Hamdard

    Advanced diploma regulatory affair

    2024

  • Nalanda and Modern Public school

    10 Matrix

    2013 — 2014

  • Joseph and Mary Public School

    12 Medical Science

    2014 — 2015

  • Jamia Hamdard

    Advanced diploma in regulatory affair

    2024 — 2025

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Nitin Sharma — Executive at Biocon in New Delhi, DL, IN | Unifers