A pharmaceutical company in India is seeking a Senior Research Associate for R&D to drive research activities in API development. The role involves conducting literature searches, lab trials, and optimizing processes while ensuring compliance with regulatory standards. Ideal candidates should have experience in pharmaceutical R&D and strong collaborative skills.
Qualifications
Experience in research and development of active pharmaceutical ingredients (APIs).
Understanding of regulatory standards related to pharmaceutical development.
Ability to conduct feasibility studies and process optimization.
Responsibilities
Execute and support research activities for API development.
Conduct literature searches and lab trials for assigned projects.
Identify critical process parameters and develop suitable reprocess methods.
Support the tech transfer team for successful process transfer from lab to plant.
Skills
Process development
Analytical testing
Literature search
Collaboration with cross-functional teams
Nitrosamine Risk assessment
Job description
Sr Research Associate, R&D page is loaded## Sr Research Associate, R&Dlocations: India - Alathurtime type: Full timeposted on: Posted Todayjob requisition id: R002587**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.Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.