Senior Research Associate

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