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
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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