Amit Gaurav
Biosimilars (Downstream) | MSAT | QMS & Data Analytics l Process Validation | Regulatory support | VCS | Process Development | Patent Agent
- Role
- Associate Manager at Biocon Biologics
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Amit Gaurav
15 years of Experience in downstream processing of molecules like Monoclonal…
Experience
Associate Manager
Mar 2023 — Present · Bengaluru, IN
Techno-managerial leadership at MSAT (Downstream) Technical oversight of Scale-up, Validation activities & Manufacturing troubleshooting. Documentations: Tech transfer, MFR preparation, Gap analysis, Risk assessment, Extractable & Leachable assessment. Manufacturing data analysis, Investigation, Process improvement, CAPA and it\'s effectiveness evaluation. Preparation of technical documents to support product filing. Preparation of scientific justification for responding to regulatory queries for US, EU, Japan, Canada & ROW market.
Education
National Law School of India University
Post Graduate Diploma
2009 — 2011
National Institute of Technology Karnataka
M.Tech.
2007 — 2009
Bapuji Institute of Engineering & Technology, DAVANAGERE
Bachelor's Degree
2003 — 2007
Skills
- Fermentation Technology
- Ion Chromatography
- Microbiology
- Gas Chromatography
- Purification
- Technology Transfer
- Ion Exchange Chromatography
- Molecular Biology
- Process Simulation
- Elisa
- Fermentation
- Chromatographic Techniques
- Validation
- Gel Filtration Chromatography
- Matlab
- Gel Electrophoresis
- Akta
- Hplc
- Ipr Law
- Enzymology
- Biotechnology
- Protein Purification
- Sds-Page
- Cell Culture
- Chromatography
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