MSAT Specialist - Downstream
1 year ago Medical & Healthcare Hyderabad 90 views Reference: 32035Job Details
- Downstream experience in a large-scale Biopharmaceutical facility and thorough knowledge of Biosimilar, mAb purification (downstream) processes and current Good Manufacturing Practices (cGMP).
- Previous experience in new product scaleup, technology transfers into a clinical and/or commercial facility.
- Experience of authoring process validation protocols and reports.
- SME of Downstream process: Hands-on experience in downstream unit operations such as Chromatography, Ultrafiltration, TFF, Virus Filtration, and handling drug substance etc.
- Working experience with protocols & report writing, risk assessment, Continued Process Verification (CPV), PAT Tools and data analysis using statistical analysis tools (like JMP).
- Technical experience working on Incidnet investigation (Deviations), OOS / OOT and sound knowledge of QMS.
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Company Description
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas.
