Job Description

Essential Duties and Responsibilities:

• Responsible for synthesizing & developing new products from lab to pilot scale with process improvement skills.
• Modification/Improvement in existing products/processes as per customer needs &
• marketing/manufacturing departmental requirements
• Handling of hazardous reaction / Name reaction / Advanced reagent.
• Experience of handling Auto clave high pressure reaction & Catalyst.
• Responsible on structural elucidation & interpretation using NMR,IR,HPLC,GC,MASS,UV Spectra etc
• Responsible for literature search with various scientific software’s. Responsible for advanced
• technologies in synthesis & analysis.
• Synthetic R&D & Process development of APIs/intermediates.
• Evaluation of risk assessment of nitrosamine impurities and PGI's.
• Optimization of cost-effective and robust process.
• Identification, preparation, characterization and different purification techniques for isolation of impurities.
• troubleshooting of the reactions & Compilation and interpretation of analytical data.
• Documentation support for technology transfer of products, DMF filing, RA queries etc.
• Active participation in the technology transfer of products from laboratory to piloting and commercialization.
• Knowledge of cGMP and regulatory guidelines
• Preparation of document like TTP, LDR, PDR, Mass Balance, BPR.
• Extensive understanding of the API research process & Well versed in process technology transfer,
• scaleup and validation in manufacturing facility
• Knowledge of all regulatory guideline & their role in API synthesis.
• API Impurity synthesis & characterisation.