Perform Downstream manufacturing batch operation in cell culture manufacturing facility following cGMP and safety practices
Perform purification steps e.g. Depth filtration, chromatography step, tangential flow filtration, viral inactivation, viral filtration, Aseptic filtration, column packing and unpacking, Integrity testing and respective documentation.
Preparation of Buffers and solution required for Executive / Senior Executive batch execution
Sterilization of materials (glassware, SS wares, garments) through steam sterilizer
Responsible for qualification of new equipment and equipment qualification document preparation. Coordination with vendors for equipment error / troubleshooting.
Operating, monitoring & maintenance of equipment & instruments located in mammalian cell culture facility.
Preparation and revision of equipment and process related SOPs
Batch record preparation and revision
Protocol & report preparation and revision
Initiation of deviations, Change controls, CAPA, quality risk assessment, Investigation report preparation & closure of the QMS documents.
Monitoring of equipment, instruments and facility, and report events or deviations.
Preparation and presenting facility for regulatory audit
Work with cross-functional departments to ensure smooth day to day activities of facility

Executive / Senior Executive - Downstream manufacturing