Tarun Kumar Gupta Email & Phone Number

Global Biosimilar Drug Substance and Drug Product Development; R&D Laboratory setup (Greenfield to fully operational); Technology Transfer & Manufacturing to Large Scale• A Result Oriented Professional with 17+ years of experience in Research & Process Development, Process and Protein Characterization, Technology Transfer, Scale up, Scale Down Model (SDM) Development, Project Management.• Expertise on Biosimilar Product filing (CMC package) and Query response for US (IR and CRL), EMA and Canada markets.• Expertise in setup different R&D laboratories from Greenfield to fully equipped and operational conditions including design layout; costing and procurement related activities.• Leading development work for and applying technical knowledge of projects in order to develop robust purification processes that scale effectively to GMP manufacturing as needed.• Expertise in team management including purification scientist and associates for development of recombinant bio-therapeutic proteins. • Review and Approval of technical reports, including SOPs, procedures, instructions, analytical plans, protocols, and summary reports.• Proficient in scientific discussions and presentation in different management meetings and leading a young group of scientists.• Designing, executing, and interpreting experimental plans including DOE; Troubleshooting experiments and Use of statistical tools for data mining and DoE analyses.• Expertise in training of manufacturing associates; Review and approval of documentation, and on-floor support.

Listed skills include Purification, Monoclonal Antibodies, Sds Page, Biotechnology, and 13 others.