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.
Requirements
- 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