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
Senior Manager, Regulatory Cmc
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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