Experience in process development of new APIs & intermediates.
Technology Transfer to plant, Process Validation at Plant.
Knowledge of process engineering, Equipment design, GMP, GLP, etc.
Literature search for process engineering, equipment design, through internet search, Literature Databases, etc.
Selection of plant feasible, cost productive and safe routes of synthesis.
Planning and execution of various experiments and reactions for process optimization.
Process optimization to develop cost productive & protected processes for APIs.
Analyzing the outcome of trials and implementing the changes accordingly.
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 considering engineering parameters.



To provide corrective & preventive actions (CAPA) through R&D; document.
Knowledge of process scale up, selection of suitable process equipments.
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).
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.

📌 Scientist Thane
🏢 RPG Life Sciences
📍 Thane