Masters degree or higher in Chemistry, Pharmacy; Well versed experience of all GMP systems including facing audits for EU, UK and other Regulated markets.
B.Pharma, M.Pharma; National Center for Disease Informatics and Research, NCDIR is one of its kind of unique institution which utilizes information science for health research as its integral component.
Prepare and review continued process verification reports for ongoing commercial products and communicate risks for taking appropriate measures for mitigation. Maintain timeline for completion of the reports along with approval.
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.
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.