Vijay Sainu Katukoori

Knowledge on large scale biopharmaceutical industry over 9 years of expertise in Upstream Manufacturing Process, Single Use Bioreactors, CQV and a Master's Degree holder in Microbiology. Currently working with Jodas Expoim Private Limited, Upstream Manufacturing(Mammalian Cell Cultures), previously Worked for Gland Pharma as Upstream Manager, Alvotech as Manufacturing Specialist Level 3 in Upstream Manufacturing Department, Syngene International Limited in Bulk Manufacturing - Upstream Process (MAb's), Hetero Biopharma Limited, Shantha Biotechnics Limited. Leading Process Investigations, Deviations, CAPAs, Change controls, BMR preparation, SOPs, Had sound experience in qualifying Single Use Bioreactors, Single Use Mixing systems. Preparation, review, approval and execution of qualification & validation documents(URS, VA, VP, SB, SLIA, CLIA, DQR, RA, FAT, SAT, RTM, IQ, OQ, PQ, IOQ, VSR) of Upstream Process Equipment.