• Product Handled: Mammalian cell culture based rHu EPO, rHu FSH Microbial based  rHu GCSF, rHu Interferon alpha, rHu PTH.
• Handling of mammalian cells suspension as well as adherent cells (r CHO cells) and microbial i. e. recombinant E. Coli.
• Cell bank preparation and maintenance.
• To carry out Planning, coordination, execution and documentation of cell culture experiments at manufacturing support lab
• Hands on experience in operation and trouble shooting of equipments like bioreactors ( 1 to 150L), roller bottle apparatus, cell bank storage system (LN2 and – 800 C), CO2 Incubator, centrifuge, TFF, refrigerator, centrifuge, cell disrupter etc.
• Expertise in bioreactor operation (SIP/CIP) and using control and data acquisition and storage systems. (SCADA)
• Preparation of documentation like MPCR, BPCR, Validation protocol, APQR, RS, IQ, OQ, PQ, SOP, and Trend analysis using MANITAB software, etc.
• Planning and control of commercial batches.
• Routine monitoring of commercial batches as well as coordination with R&D regarding technology transfer and development of new product mainly upstream process.
• Supervision of workers who operate the equipments like bioreactors, water systems, housekeeping activities at the level of cGood manufacturing practice.
• Investigation, documentation, to take corrective and preventive action (CAPA) in case of failure of process.
• Responsible for establishing, implementing, monitoring and maintaining Quality System in the ***** ceutical Bulk Manufacturing area related to cGMP regulation of the various countries from the Regulated and Semi regulated market.
• To give training to subordinate regarding company policy, cGMP, biosafety and on job duties.
• Responsible for material selection and costing of general activity of production.