Conducting lab experiments for the process development of assigned API, synthesis of process related impurities, NDSRIs and other nitrosamine impurities. Maintaining safe working environment.
Requirements
- 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.