◆Nearly 14+ Years of experience in Development, Scale-up and validations of various APIs at bulk level.◆Working closely with all stake holders like R&D, Production, QA/QC, RA etc. for timely validations and scale-up of new molecules with first time right approach.◆Development and optimization of process for Bulk drugs on commercial scale by managing operations such Column Chromatography, Crystallization, High vacuum and Fractional Distillation.◆Quality analysis of APIs & intermediates with result Interpretation as GC, HPLC, IR, NMR, MS and other routine analytical techniques.◆Establish technology at Kilo lab scale and pilot plant scale. ◆ Use of Lab max reactors for plant simulations with different agitators, addition patterns etc. for reactions as well as polymorphism studies.◆Generate the required what-if, material balance; establish solvent recoveries, effluent detailing, etc◆Equipment selection designing, installation & commissioning as per the process requirement and preparation of P& ID. ◆Executing the trial & validation batches of individual projects at manufacturing facilities for timely DMF fillings.◆Planning & executing the project successfully at the facility by interacting with various departments.◆Identification for new areas for reduction in solvent & raw material consumption for various drugs.◆Carry out Hazop at plant with related departments. ◆Trouble shooting on plant scale for regular commercialized molecules.◆Ensure proper documentation of scale up as per cGMP & customer’s requirement.◆To participate in CAPA initiations for the root cause of the failures OOS,s OOTs and deviations during Tech. Transfer.◆Preparation of Technical docket after completion of the project.◆Conduct training program on technical /safety related topics.