Executive - R&D (API)

RPG Life Sciences; Thane, Navi Mumbai, Mumbai; On-site; INR 800,000 - 1,600,000; Full time

Job summary

RPG Life Sciences is seeking a skilled professional for API and intermediate process development, with responsibilities spanning technology transfer to plant facilities and ongoing process optimization.

The role requires strong knowledge of GMP/GLP and regulatory guidelines, plus hands-on experience in analytical characterization (NMR, Mass Spec, HPLC, DSC, TGA).

Qualifications

• Experience in process development of APIs & intermediates.
• Knowledge of GMP/GLP and regulatory guidelines.
• Planning and executing experiments for process optimization.
• Technology transfer and scale-up to plant facilities.

Responsibilities

• Develop cost-efficient and scalable processes for APIs and intermediates.
• Perform literature searches and evaluate synthesis routes.
• Coordinate with QA/RA for regulatory data and documentation.
• Oversee OOS investigations and CAPA implementations.
• Collaborate with cross-functional teams for successful tech transfer.

Skills

Process development

Tech transfer

Analytical methods

Quality systems

Education

M.Pharm/PhD in Chemistry

Bachelors in Chemistry

Tools

NMR

Mass Spec

HPLC

DSC

TGA

Job description

Role & Responsibility: Process development of new products, Execution of experiments, Technology Transfer, Cost Reduction, Plant Troubleshooting, OOS Investigation.

Responsibilities Handled:

• 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.