Executive

6 days ago


India Biocon Full time

Department DetailsRole Summary1 Driving new facility design Concept Basic and Detailed engineering design with focused effort on Upstream and Downstream Unit operations 2 Support 2KL SU and 6 KL SS mAb manufacturing facility Scale up and technology transfer 3 Upstream and Downstream equipment and process trouble shooting Bioreactors Centrifuge chromatography skid Filtration systems UFDF TFF Filling station Freeze Thaw etc 4 Knowledge on Monoclonal antibody manufacturing process and support production operations 5 Handle CAPEX requirements for multiple drug substance facilities - 2KL and 6 KL scale 6 Key driver to bring new technology and systems into production facility 7 Active support in Process and Cleaning validation 8 Drive process automation for equipment s - Handling recipes phases etc 9 Drive process trouble shooting and investigation with CAPA identification 10 Perform Technology transfer facility fitment assessment for new products 11 Handle software tools like SuperPro SchedulePro Process simulations 12 Perform process analytics model creation using SIMCA and other standard analytical tools 13 Drive the equipment Qualification review of FAT SAT protocol and preparation of in-house DQ IQ OQ and PQ protocol and report 14 Basic Automation knowledge for recipe Siemens PCS7 CCP Unicorn and other platforms and MES support 15 Complying with EHS policies 16 Complying with cGMP practices as per SOP batch records and protocols 17 Preparation and review of cGMP documents like SOP batch records checklists registers protocols and reports Key Responsibilities1 Driving new facility design Concept Basic and Detailed engineering design with focused effort on Upstream and Downstream Unit operations 2 Support 2KL SU and 6 KL SS mAb manufacturing facility Scale up and technology transfer 3 Upstream and Downstream equipment and process trouble shooting Bioreactors Centrifuge chromatography skid Filtration systems UFDF TFF Filling station Freeze Thaw etc 4 Knowledge on Monoclonal antibody manufacturing process and support production operations 5 Handle CAPEX requirements for multiple drug substance facilities - 2KL and 6 KL scale 6 Key driver to bring new technology and systems into production facility 7 Active support in Process and Cleaning validation 8 Drive process automation for equipment s - Handling recipes phases etc 9 Drive process trouble shooting and investigation with CAPA identification 10 Perform Technology transfer facility fitment assessment for new products 11 Handle software tools like SuperPro SchedulePro Process simulations 12 Perform process analytics model creation using SIMCA and other standard analytical tools 13 Drive the equipment Qualification review of FAT SAT protocol and preparation of in-house DQ IQ OQ and PQ protocol and report 14 Basic Automation knowledge for recipe Siemens PCS7 CCP Unicorn and other platforms and MES support 15 Complying with EHS policies 16 Complying with cGMP practices as per SOP batch records and protocols 17 Preparation and review of cGMP documents like SOP batch records checklists registers protocols and reports Educational QualificationsRequired Education Qualification Msc Required Experience 1 - 4 years


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