Role Summary: • Handling of projects for Global Regulated Market ( EU, ROW and Domestic) • Execution of the assigned projects from development to commercial scale. • Communication and coordination with cross-functional teams. Principal Tasks and Responsibilities: • Development of Pharmaceutical solid (IR/MR) and liquid oral (Solution/Suspension) drug Product for Global market. • Literature survey, Patent analysis and preparation of literature survey and patent search report. • Design and execute experiments to develop robust, stable and bioequivalent formulation as per Quality by Design (QBD) principle. • Handling of new software tools that can help to optimize the work such as DOW, Minitab etc. • Identify and indenting project materials requirements (i.e. API, Excipients, tablet tooling. Equipment component, change parts etc.). • Reverse engineering of Innovator formulation to understand the critical parameters to minimize the development batches • To plan the batch sizes for scale up batch, process optimization batches, exhibit batches to meet the equipment capacities and regulatory requirements with minimum consumption • To execute and evaluate the scale up batch, pilot batch, process optimization and Pre-exhibit and exhibit batches • To be part of trouble shooting activities in commercial batches • Evaluation and interpretation of analytical data of all type of batches • Design and conduct stability and compatibility studies • Meeting product development timelines • Preparation of documents like PDR, BMR, regulatory response documents and stability protocols • Active role in selection of formulation and data interpretation for bioavailability study • Well efficient in handling of SAP for indenting and reservation of materials • Monitoring Pre formulation and stability batches and compilation of stability data
