Knowledge of handling SCADA base coating machine. Knowledge of equipment in granulation and able to handle Integrated Granulation Line PLC based equipment
Responsible for Monitoring and Completion of the production batches as the scheduled timelines. Responsible for implementation of the cGMP practices in the area. Responsible for Indenting of the production process related accessories and consumables.
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.
B.Sc. in Radiological Imaging Technology from a recognized University with 50% marks OR B.Sc. in any subject with 50 % marks, B-Pharmacy with 50% marks and minimum 2 years Diploma in Medical Imaging Technology from State Board of Technical Education OR any equivalent recognized Board/ University.
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.