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
About Nitin Sharma
Quality Control, Quality Assurance, and Regulatory Affairs (CMC)-aligned pharmaceutical…
Experience
Executive
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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