Bimlesh Kumar
Assistant Manager-Biosimilar Production Upstream (Microbial)
- Role
- Assistant Manager-biosimilar Production Upstream (Microbial) at Biocon Biologics
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Bimlesh Kumar
A microbiology postgraduate with over 13 years of experienced in QA & QMS, Process development (Upstream-Mammalian), Manufacturing (Upstream-Microbial), Operations & Team Management.
Experience
Assistant Manager-biosimilar Production Upstream (Microbial)
Dec 2021 — Present · Bengaluru, IN
Working for Production of Biosimilar product (Pegfilgrastim) based on E.Coli fermentation.\\\\n- Handling and Supervision of all shop floor activities for commercial batches.\\\\n- Operations of different instruments:\\\\na. Sartorius 225L fermenter\\\\nb. IDMC 100L media vessel\\\\nc. DDE 50L media vessel\\\\nd. Sartorius 300L harvest vessel\\\\ne. GEA Homogenizer for Cell lysis\\\\nf. Alfa Laval Continuous centrifuge & Thermo Fisher Batch centrifuge for Cell clarification & IBs separation.\\\\ng. Shimadzu UV-Vis 1900 Lab Solutions spectrophotometer for OD measurement\\\\nh. PHT, SIP system for sterilization and CIP for cleaning of various instruments\\\\ni. Sartocheck for filter integrity test\\\\nj. Sartorius 150L surge vessel - for solubalization of IBs\\\\n- Inoculum generations through different seed stages for Fermenter.\\\\n- Preparation and Review of different process protocol and its respective reports.\\\\n- Preparation and Review of quality documents such as BMR, SOP, Checklist.\\\\n- Initiations and closure of QMS activities such as Deviations, Change Control, CAPA, Investigation Report in Quality Management System Software \"Trackwise\".\\\\n- Collaboration with MSAT, QMS & IPQA team for process improvement.\\\\n- Faced audits like US FDA, EMA, ANVISA, CDSCO and contributed in enforcing cGMP compliance across shop floor through internal audits/ self-inspection.\\\\n- SAP Operations: Inventory Management (Raw Materials & Consumables)\\\\n- Team Management and Operations supervision (Feed, Solutions, Buffer, Seed & Production Media and Assembly Preparations).\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Education
Allahabad Agricultural Institute
BSc.(H) , Microbiology, General
2006 — 2010
HimalayanUniversity
MSc. , Microbiology, General
2016 — 2018
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