- Ph.D. in Organic Chemistry from a reputed university.2. More than 05 years of industrial experience in API R & D from a reputed pharma company.3. Have adequate knowledge of Regulatory requirements, DMF preparation and regulatory filings.4. Ensure the proper documentation practices, report preparation and the ability to present thedevelopment activities5. Have the ability to work with multiple projects and timely deliverance.6. Worked for process improvement, cost reduction, vendor approval, plant troubleshooting, andInvestigation of failures7. Sound knowledge of IPR, regulatory filing requirements, Genotoxic impurities, N-Nitrosoimpurities identification and control requirements8. Ability to design non-infringing, cost-effective & scalable synthetic routes.9. Scientific knowledge of developing robust and safe processes for desired quality API.10.
Current Positive Laboratory
Practices.11. Awareness of Laboratory Safety.12. Purge studies for specification fixation of key starting materials, intermediate and Rawmaterials.13. End-to-end product development cycle from lab scale to commercial Scale.14. Thorough understanding of critical process parameters.