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Sr Research Associate, R&D chez Endo

Endo · Alathur, Inde · Onsite

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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.

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