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
Endo Navi Mumbai, Maharashtra, IND Office
Rabale Midc Road, Navi Mumbai, Maharashtra , India, 400701
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