Alathur, IND
19 days ago
Sr Research Associate, R&D
**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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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