Candidate should have experience in - Executing CAR-T cell production at lab scale and / or clinical / commercial scale including isolation of T cells, activation and transduction etc.
Supervise production team operations. Handle equipment: Sifter, FBD, Dryer, Centrifuge, ANF, Spray Dryer, Reactor, etc.
Ensure compliance with GMP processes. Maintain BMR, BPR, and logbooks.
B.Pharm / M.Pharm / M.Sc. ; Handling of complex injectable products and peptide molecules analysis. Core competency to take care of CMO, CDMO products. Ownership on Testing and compliance.
Compounding, Filling, Vial Washing, Tunnel, Autoclave, Capping, and Packing activities. Disinfectant, MLT, BET, and sterility method validations, executions, and related documentation, Culture handling & EM monitoring.
Strong leadership, decision-making, and communication skills. Strategic thinking with operational execution capability.
Excellent knowledge of hospital information systems and digital healthcare platforms.