The Senior Research Associate executes research on active pharmaceutical ingredients, focusing on synthesis, characterization, process optimization, and regulatory compliance. They lead lab trials and collaborate cross-functionally for successful API development.
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.
Top Skills
Analytical Testing
Characterization
Lab Trials
Process Development
Regulatory Compliance
Synthesis
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