Executive - R&D (API)

Actis Generics Private Limited; Madhurawada, Visakhapatnam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Actis Generics Private Limited is seeking a candidate with extensive experience in process development for new APIs and intermediates, including technology transfer to plants and process validation. The role involves literature and patent searching, retrosynthesis, and ensuring regulatory compliance with GMP/GLP guidelines.

The position requires planning and executing experiments, optimizing processes for cost efficiency and safety, and coordinating with QA, RA, and cross-functional teams to

Qualifications

• Experience in process development of new APIs & intermediates.
• Technology Transfer to plant, Process Validation at Plant.
• Literature search for new molecules through internet search, Scifinder, etc.
• Patents search and patent evaluation.
• Selection of plant feasible, cost efficient and safe routes of synthesis.
• Development of non-infringing route for API, knowledge of retrosynthesis.
• Knowledge of regulatory guidelines, GMP, GLP, etc.

Responsibilities

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

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.