Research Associate, R&D-3

Job Description Summary

Conducting lab experiments for the process development of assigned API, synthesis of process related impurities, NDSRIs and other nitrosamine impurities.
Performing susceptibility trial for DS/DP. Maintaining safe working environment.

Job Description

• Conducting 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.
• Carrying out 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.