 Based on SAR studies, Preparation of multi-step NCE and submitting for their Biological activity. Based on microbial study the in-house NCE’s (WCK molecules) was further scaled-up in kilo level and supplies towards for In-vivo, Dog-PK, toxicology study and further clinical studies.designing and executing the synthesis pathway for novel target molecules/NCE’s/derivatives towards growth of organization. Process development and scale-up for in-house new drug/NCE molecules. I have worked on NCE’s molecules /derivatives of Cephalosporin, Fluoroquinolone, Ketolides-macrolides, Oxazolidinone, Avibactum (Extended Spectrum Beta Lactamase-ESBL)/ Beta Lactamase Inhibitors (BLI), Monobactum derivatives. Thoroughly going through literature (Both Manual and electronic literature) and select best possible economical viable scheme for NCE’s synthesis. Perform synthetic chemistry reactions, work-up, Isolation, purification of the compounds by column chromatography, flash column-chromatography, crystallization, re-crystallization techniques, preparative TLC/HPLC methodology. Isolation, characterization and synthesis of related impurities generated during synthesis of clinical candidate molecule (NCE’s). Identification of impurities/ Impurity profiling. Considering the importance of pro-drugs many of the pro-drugs were prepared for better drug delivery. Preparation of amorphous and crystalline polymorphism compounds for promising clinical candidate molecule. Interpretation analytical/spectral data’s like 1H-NMR, COSY, NOESY, 13C-NMR, UV, GC, IR, SOR, HPLC, MS, LC-MS, GC-MS, PXRD, DSC, DGA, wet analysis, single crystal study, structure elucidation, etc. Fixation of specification of key raw material, intermediate and clinical candidate molecule. Also handling the additional responsibility to maintain the Lab.

 Multistep Custom / Organic Synthesis (CRAMS) of hetero Cyclic and chiral molecules. Have to do reaction with parallel synthesizer. Preparation of the weekly and monthly development reports. Working on the molecules with quality, quantity, cost, time line, safety and GLP consciousness. Distillation techniques like steam distillation, fractional distillation, high vacuums distillation. Troubles Shooting in view of cost reduction, safety, yield improvements, purity improvement, etc. Conducting multi-step organic synthesis as well as isolation and purification techniques. Demonstrating product scale-up in kilo lab and making process development report (PDR). Isolation and characterization of the desired products as well as side products in every step during multi-steps. The products purified through column and flash column-chromatography. Have a set of principles that laboratory studies, performed, monitored, recorded, reported and achieved. Involved in planning, scooping, estimation, tracking of new routes/ route selection. End to end responsibility project management through cross functional teams, Process developed and scaled-ups.

 To develop non-infringing and cost effective process development for Active Pharmaceutical Ingredients (Generic-API) & modification of existing ones based on market feedback & trends. Making documentation for finished product, arrange the technology transfer report (TTR) as per regulatory requirement. Preparation of working standards, all API’s related impurity and conformed by analytical results. Inputs for DMF filling, understand and assisting the IPM/IPR-related issues. As a research executive leading and guiding 2-3 chemists in the process research development (PRD) and scale up division. Motivating team members to achieve organization goal. Planning to promote the product grams level to kilo level. Demonstrating the product preparation in pilot plant and API bulk plant demonstration (GMP). Conducting high-pressure autoclave reactions. I have done projects: Simvastatin, Carvedilol, Risperidone, Aprepitant, Esomeprazole and Carvedilol Phosphate hemihydrates. Ordering of raw materials, doing feasibility of reaction, optimization and fine tuning of reaction, yield makes to constant, lab assurance batches, cost reduction, waste minimization, recycling, simplifying the process, improving the selectivity, facilitate the handling, kilo-lab validation batches. To fix the specification of API and intermediates. To face organic residual solvent problem in final APIs with well versed technology. Organic molecule synthesis/Impurity synthesis/working standard synthesis. Interpretation of analytical/spectral data’s 1H-NMR, 13C-NMR, COSY, NOESY, UV, GC, IR, SOR, HPLC, MS, LC-MS, PXRD, DSC and TGA. Preparation of manufacturing sheets and HAZOP Studies, considering cGMP and FDA. Preparation of amorphous compound and polymorphism study. Maintain detailed Laboratory Note Book (LNB) of the result. To plan and monitor the stability studies and analyze the stability data. Identification of impurities/ Impurity profiling.

 Worked in the process development division to make new process for basic drugs and drug intermediates. (API-Process development). Worked on multi-step API’s like Ciprofloxacin.HCl.H2O, Omeprazole, Esomeprazole, Clorsulon, Entroflaxacin and drug intermediates like 2-mercapto-5-methoxy-benzimidazole, Chloro compounds and Hydroxy methyl compound. Lab assurance batches in R&D, pilot plant trials/ scale up and process transfer to manufacturing bulk drug plant along with Technology Transfer Report and demonstration/ Process Development Report (TTR/PDR). Cost reduction, Recycling solvents, effluent reducing, reduce the batch cycle time, making reprocessing method, user test study for plant raw materials, yield increase study, quality improvements and safety. Process research, process development, process optimization and more knowledge in-process check by TLC. Good experience to handle air, moisture, temperature and light sensitive compounds. Laboratory SOPs, Safety manuals and analytical results are maintained excellent manner. Lab maintained in cleanliness. Solving the production problem, doing high vacuum distillation and fractional distillation using packed columns. Handle additional responsibilities as delegated by Supervisor.