- Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records for Biologics - Performing the production activities of Biosimilar Drug Substance - Operation of 5L, 100L and 1500 L fermenter - Operation of Protein purification system ( Akta Prime, Akta Pure and Akta Pilot) and TFF system - Operation of all the equipment required for Upstream and Downstream process of Biosimilar Drug Substance - Maintaining records to comply with regulatory requirements. - Monitoring manufacturing processes and in process results of different unit operation - Preparation and review of documents as per regulatory requirement like MMD, SOPs and other technical documents - Readiness of facility for internal and external inspections - Troubleshoot the technical issues in consultation with the Production Head during the shift duties. - Participate in audits and investigations to recommend solutions and justifications and resolve problems - Culture propagation and preservation for bacterial and Mammalian cells. - Provide training to new personnel in a specific technical process - To carry out the In-process analysis during the batch operation and Testing of cell bank - Coordinating with different departments for timely manufacturing of biologics and with external agency for shipment of sample and discard of waste materials - Ensure safe and efficient operation of Production equipment following safety procedure in order to protect the safety of themselves and their colleagues - Schedule and monitor regular maintenance of equipment and facility in coordination with engineering team
