Manager Injectables And Oral Solids
CurrentParenterals:-Setup of Parenteral Laboratory starting from Area design, Equipment identification, qualification to implementation of key SOPs and Systems for effective product development and technology transfer of Lyophilized, Liquid and Powder for injection for global markets-Formulation and Process optimization required for development of Parenteral products such as Lyophilized, Liquid (Non-aqueous and aqueous) and Powder for Injection-Implementation of Quality by Design at different stages of Formulation development of Parenterals-Scale-up and technology transfer of Lyophilized, Liquid (Non-aqueous and aqueous), Powder for Injections to manufacturing site or international CMOs-Optimization and development of design space for Lyophilization process-Selection, optimization and regulatory requirements of Terminal sterilization cycle-Aseptic filtration, Filter validation studies and regulatory requirements- Extractables and Leachables for different process component, packaging material and drug product-Glass delamination study-Characterization and data interpretation of DSC, PXRD, Reverse engineering of Reference product Solid Orals:-Formulation & process optimization required for development of Immediate Release, Modified Release, Gastric Resistant Oral Formulations-Successful Scale-up of process like Wet Granulation, Roller Compaction, Granulation by top spray to different international partner CMOs-Design of Experiments and Minitab application in QbD based drug product development & scale-up-Simulation and establishing In-vivo and In-vitro correlation-Handling of Cytotoxic substancesTeam Management:Training and management of team of skilled scientists and senior scientistsProject Tracking and Management:-Capex and product Budget-Project Timelines and trackers-Presentations for Product development, Stage gate and Review meetings-Plan & Co-ordination with Analytical, RA, IP, PM, Purchase, Production & other CFTs to achieve agreed milestones
