5+

Manufacturing, filtration, filling, Lyophilization, sealing, and pre- and post-manufacturing activities. Planning and execution of batch manufacturing activities, filling activities, lyophilization, sealing activities, and filter integrity. Monitoring NVPC and trending.

M. Pharma / B. Pharma; Awareness of regulatory requirement, ANDA filing & new Product filing application, Handle Field Alert Report, Market complaint, Review & presentation of Data, Tracking of data. Planning for sample pullout, Batch charging, storage & reconciliation, destruction & smooth functioning of Stability chamber, Walk-in Chamber

Candidate will be expected to have worked with primary cells and cell lines in immunology or immuno-oncology context. Prior experience working in development and validation of cell and gene therapy products will be preferred. M.Sc / M.Tech in Biotechnology

Analytical method validation of different methodology. Dissolution Method Development and validation. Validation and method development protocol and report preparation.

Formulation development of Injectable including development, execution, filing and approval of Complex Injectables viz. Liposomes, Peptides, long acting emulsions, suspensions, in-situ gels, Lyophilised injectable etc.

Conduct QC testing on raw materials, packaging, stability, in-process, and finished products. Capable of Handling Instrument like HPLC, GC,KF, IR,UV instrument. To review analytical data & handling of QMS i.e. Deviations, 00S, 00T, Laboratory incidences, OOC, CAPA and Effectiveness of CAPA.

Monitor and supervise production process to ensure compliance with SOP and cGMP. Maintain documentation as per regulatory authorities requirement like change control, deviations. Highlight technical problems and take corrective actions.

Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science. Understanding of medical practices regarding procedures, medications, and treatment for different disease states.