R&D Drug Product Development

Job Description

Job Summary: The role involves executing various drug product development studies, preparing stability protocols, compiling data, conducting trend analysis, and preparing stability reports for projects. The responsibilities include supporting technology transfer, troubleshooting issues with finished products, coordinating stability studies with other departments, and handling related equipment maintenance. Key Responsibilities: Prepare draft reports for formulation development summaries and stability data. Support technology transfer and process validation batches. Troubleshoot issues related to the finished product process. Execute stability studies in coordination with other departments and prepare reports. Handle and maintain stability chambers and instruments, as requested by the supervisor. Provide training to trainees. Review stability data generated using various techniques, including chromatography. Prepare responses to queries from different regulatory markets. Plan and execute various drug product development studies, such as Filter Adsorption Study, Tubing/Closure Compatibility, Hold Time Study, Shear Stress, and Freeze/Thaw Study. Respond to QA observations and close reports; review and ensure SOP compliance