1.Direct and manage a team of scientists for the planning and execution of product development activity for Domestic/ROW/ANDA projects of Parenteral / Ophthalmic, Lyophilized, Liquid Injections in Ampoules, vials, PFS, Emulsions and suspensions, & Novel Drug Delivery Systems (NDDS) .2.Plan detailed activities related to formulation development in line with QbD concepts and execution shall be done within targeted time limits.
3.To review product literature and patent for Quantitative and Qualitative Pre- formulation studies of Recent Products as per Regulatory requirements.
4.Formulation designing, Process optimization studies during development and support Scaleup as well as Transfer of Technology from F&D; Department to Manufacturing unit.
5.Understand / familiarize with the problems faced during Scale-up & Overseeing implementation of Critical Process Parameters (CPP) for Validation / Commercials at plant.
6.Plan, perform and contribute to project related scientific / technical activities (e.g., interpretation of results, data evaluation, draw relevant conclusions and write reports).
7.To check pharmaceutical development reports for the same and to give inputs for regulatory filings.
8.To coordinate with various cross functional teams for timely meeting the F&D; projects completion schedules.
9.To check departmental SOPs, MFRs, Protocols and Reports related to the product.
10.To guide or mentor the teammates with valuable inputs and recent developments in the pharma field.
11.Interacting with machine manufacturers and review the machine design.