Executive - R&D (API)

RPG Life Sciences; Kamareddy; On-site; INR 900,000 - 1,350,000; Full time

Job summary

RPG Life Sciences in India is seeking a seasoned process development professional to advance new APIs and intermediates from discovery through tech transfer to plant validation.

You will design experiments, optimize routes, evaluate impurities, support regulatory queries, and coordinate with QA, RA, and manufacturing while ensuring GMP/GLP compliance and CAPA across sites.

Qualifications

• Experience in process development of new APIs and intermediates.
• Technology transfer to plant and process validation at plant.
• Familiarity with GMP/GLP and regulatory guidelines.

Responsibilities

• Plan and execute experiments to optimize process parameters for APIs.
• Develop cost-efficient, scalable synthesis routes with safe practices.
• Perform literature and patent searches to inform process decisions.
• Interpret analytical data (NMR, MS, IR, DSC, TGA) to guide improvements.
• Coordinate cross-functional teams for tech transfer and plant support.
• Prepare technology transfer documentation and CAPA reports.

Skills

Process development

Technology transfer

GMP/GLP knowledge

Regulatory liaison

Analytical thinking

Tools

NMR

Mass spectrometry

IR spectroscopy

DSC

TGA

Job description

1. Experience in process development of new APIs & intermediates.
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. Knowledge of regulatory guidelines, GMP, GLP, etc.
8. Planning and execution of various experiments and reactions for process optimization.
9. Analyzing the outcome of trials and implementing the changes accordingly.
10. Designing specifications for the Key Starting materials, in-process Tests, intermediates, APIs.
11. Process optimization to develop cost efficient & safe processes for APIs.
12. Identification of critical process parameters, challenging experiments, experimentation as per QBD.
13. To develop processes for various polymorphs & their testing.
14. Interpretation of various analytical reports, characterization of molecules by NMR, Mass, IR, DSC, TGA, etc.
15. Preparation of Technology Transfer Document (TTD).
16. Plant trouble shooting & OOS/OOT investigations. To provide corrective & preventive actions (CAPA) through R&D document.
17. To develop reprocessing methods for OOS batches; implementation of reprocessing methods & CAPA at plant.
18. Support to KSM vendor development process by carrying out user trials of various vendors samples and preparation of document for the same.
19. Co-ordination with analytical development Lab (ADL) for routine analysis.
20. Daily reporting to Manager, writing the experiments in Lab Note Books (LNB).
21. Support to QA/RA/Marketing for regulatory queries, customer queries, technical data, samples, etc.
22. Evaluation of APIs for Impurity Profile, Genotoxic/Nitrosamine impurities and providing the relevant data to QA.
23. Cost reduction of existing APIs and process improvement.
24. Solvent recovery, recycle and implementation at plant.
25. Co-ordination with cross functional teams or departments like ADL, Production, QC, QA, RA, Marketing, Finance, HR, Safety (EHS), etc.
26. Outstation travel & stay at CMO sites for technology transfer at various locations.
27. Lab maintenance, documentation.