Neeru Sharma
- Role
- Cell Line Development Upstream Downstream Process Development Quality at AGC Biologics
- Location
- Austin, TX, US
- LinkedIn followers
- 500 followers
About Neeru Sharma
A skillful expert in the field of biologics process development for mammalian recombinant…
Experience
Cell Line Development Upstream Downstream Process Development Quality
Jun 2021 — Present
Responsible for Quality Assurance of bioprocess manufacturing operations such as solution compounding, filtration, TFF, filling including dispensing, solution preparation, and filtration Creation, identification & Review of GMP documentation & execution of unit operations described in standard operating procedures and batch records. Completion of deviation reports, change control, product changeover, etc. Responsible for compliance with company quality systems, safety procedures, and other company policies • Quality Assurance, Regulatory Affairs, Pharmaceutical, and Biopharma industry regulations • Lean principles, FDA regulations, SOP, cGMP, ICH, Pharmaceutical, Bioprocess, Bio-reaction engineering • Bioprocess technology transfer, Bioreactor design, Biopharma facility design & operations • Mammalian cell/CHO cell line, Recombinant DNA technology, Laboratory training • Formulations & delivery of Protein, Upstream/downstream biopharmaceutical process • TOC (Total Organic Carbon), Conductivity, LIMS (Lab Information Management Services), Bioburden (Utilities & Product), ISO 19011- for Audit Mgmt. Systems. • Pharmaceutical Manufacturing, Cleanroom experience, Sample mgmt, Microbiology & Fab experience.
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