Manager - R&D (API)

RPG Life Sciences; Kamareddy; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

RPG Life Sciences is seeking a leader to drive process development for new APIs, oversee tech transfer to manufacturing plants, and validate processes at the plant site. The role includes literature and patent searches, route selection that balances cost and safety, and developing non-infringing synthetic pathways for APIs.

You will also handle costing, regulatory literacy, and CAPA-driven improvements. The ideal candidate will have strong experience in QBD-driven experimentation, project

Qualifications

• Experience in team leadership for process development of new APIs.

Responsibilities

• Technology Transfer to plant, Process Validation at Plant.
• Literature search for new molecules via internet search and Scifinder.
• Patents search and evaluation.
• Selection of feasible, cost-efficient, safe synthesis routes.
• Develop non-infringing routes for APIs and retrosynthesis knowledge.
• Prepare costing and development cost sheets.
• Knowledge of regulatory guidelines, GMP/GLP.

Job description

1. Experience in Team Leadership for process development of new APIs.

2. Technology Transfer to plant, Process Validation at Plant.

3. Literature search for new molecules through internet search, Scifinder, etc.

4. Patents search and patent evaluation.

5. Selection of plant feasible, cost efficient and safe routes of synthesis.

6. Development of non-infringing route for API, knowledge of retrosynthesis.

7. Preparation of costing sheet & to prepare development cost sheet.

8. Knowledge of regulatory guidelines, GMP, GLP, etc.

9. Planning and execution of various experiments and reactions for process optimization.

10. Analyzing the outcome of trials and implementing the changes accordingly.

11. Designing specifications for Key Starting materials, in-process checks, intermediates and APIs.

12. Process optimization to develop cost efficient & safe processes for APIs.

13. Identification of critical process parameters, challenging experiments, experiments as per QBD.

14. To develop processes for various polymorphs & their testing.

15. Interpretation of various analytical reports, characterization of molecules by NMR, Mass, IR, DSC, TGA, etc.

16. Preparation of Technology Transfer Document (TTD).

17. Plant trouble shooting & OOS/OOT investigations. To provide corrective & preventive actions (CAPA) through R&D document.

18. To develop reprocessing methods for OOS batches; implementation of reprocessing methods & CAPA at plant.

19. Support to KSM vendor development process by carrying out user trials of various vendors samples and preparation of document for the same.

20. Co-ordination with marketing department for any requirement of documents, impurity or standard samples for customer.

21. Daily reporting to Manager, Preparation of monthly reports.

22. Support to QA/RA/Marketing for regulatory queries, customer queries, technical data, samples, etc.

23. Evaluation of APIs for Impurity Profile, Genotoxic/Nitrosamine impurities and providing the relevant data to QA/RA.

24. Cost reduction of existing APIs and process improvement.

25. Solvent recovery, recycle and implementation at plant.

26. Preparation of response to queries related to audit observations, regulatory agencies and statutory requirements.

27. Co-ordination with cross functional teams or departments like ADL, Production, QC, QA, RA, Marketing, Finance, HR, Safety (EHS), etc.

28. Identification of contract manufacturing sites (CMOs) as and when required for new products and technology transfer at CMO sites.

29. Leading the team for technology transfer to CMOs, preparation of protocols for R&D lab trials, lab demonstration reports and involvement in equipment mapping for scale up.

30. Outstation travel & stay at CMO sites for technology transfer at various locations.