Varsha Ganesh

Role
Senior Manager, Regulatory Cmc at Bristol Myers Squibb
Location
New Brunswick, NJ, US
LinkedIn followers
500 followers
Manufacturing & ProductionView LinkedIn profile

About Varsha Ganesh

Regulatory CMC professional with over 12 years in the pharma/bio-pharma space. Have…

Experience

  1. Senior Manager, Regulatory Cmc

    Bristol Myers Squibb

    Sep 2020 — Present

    Work on regulatory strategy for CMC submissions, both for Clinical Trial Applications and New Marketing Applications. • Work with the CMC team to compile IMPDs and Module 3 documents. • Respond to Health Authority queries on BMS products.

Skills

  • Fluorescence Microscopy
  • Validation
  • Flow Cytometry
  • Dna Extraction
  • Microscopy
  • Western Blotting
  • Internal Audit
  • Recombinant Dna Technology
  • Cell Culture
  • Chromatography
  • Change Control
  • Gel Electrophoresis
  • Cgmp Practices
  • Protein Purification
  • Sds-Page
  • Elisa
  • Pcr
  • Quality System
  • Molecular Biology
  • Biochemistry
  • Quality Operations

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Varsha Ganesh — Senior Manager, Regulatory Cmc at Bristol Myers Squibb in New Brunswick, NJ, US | Unifers