About this role
Job Description Summary
The Senior Research Associate in API- Research and development is responsible for executing and supporting research activities related to the Literature search, Synthesis, Characterization, and scale-up of active pharmaceutical ingredients. This role involves Process development, analytical testing, documentation, and collaboration with cross-functional teams to ensure the successful development of high-quality APIs in compliance with regulatory standards.
Job Description
• Research and process development of API. • Conducting Literature search, lab trials and stretchability studies for the assigned API. • Carrying out feasibility studies for the assigned projects. • Identifying critical process parameters and developing suitable reprocess methods. • Process optimization and carrying out lab validation batches. • Synthesis of process related impurities • Conducting lab feasibility studies and identifying the critical process parameter. • Conducting stretchability studies and identifying critical process parameters • Supporting the tech transfer team for the successful process transfer from lab to plant. • Synthesis of NDSRIs and other nitrosamine impurities and characterization. • Carrying susceptibility trial experiments of drug substances/drug products under various Nitrosation conditions. • Nitrosamine Risk assessment based on API structure, its route of synthesis, related impurities, and excipients used in the manufacture of drug substances. • Maintaining lab environment safely, cleanly, and guiding Lab Assistant to handle hazardous chemicals.