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.

Skills Required

Synthesis, Process Optimization, Feasibility Studies, Documentation, characterization, Process Development