Gaurav Singh
Downstream Process Expert | MSAT Professional | Tech Transfer | Product Lifecycle & Scale-Up
- Role
- Deputy Manager (Msat) at Biocon
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Gaurav Singh
As a postgraduate in Biotechnology with over 11+ years of industrial experience. I…
Experience
Deputy Manager (Msat)
Mar 2023 — Present · Bengaluru, IN
Establishing/managing functional goals of teams in alignment with organizational and departmental goals.2. Authoring/reviewing the investigation report with appropriate impact assessment and CAPA for Downstream process Deviations.3. Authoring/review protocol and technical reports to support process changes, modification, improvement and scale up at 2kL manufacturing scale.4. Review of new processes and new products and the associated technology transfer.5. Guidance for scale down experiments to support process Deviations/non-conformities to identify the root cause.6. Product life cycle management: Authoring/review of Resin and TFF life cycle evaluation protocols and reports.7. monitoring of Continued Process Verification: Analysis of batch data, trends and investigation of Shift/drift in process with appropriate CAPA in CPV report.8. Troubleshooting and determining root causes for process Deviations, OOT, in process and DS & DP stability related OOS investigations.9. In process & Stability data evaluation and Statistical analysis from using JMP.17 software for process inveatigation, robustness and yield improvement.10. Representing MSAT and providing technical inputs during regulatory or customer audits.
Education
Bangalore University
M. Sc. Biotechnology, Molecular Biology, Genetic Engineering, Immunology, Bioprocess Engineering, ABT, PBT
2011 — 2013
Indian Statistical Institute(SQC & OR)
Statistics
CMR Institute Of Management Studies
M.Sc. Biotechnology
2011 — 2013
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