Sivakumar V. Aathimanikandan

WORK HISTORY

EDUCATION

SKILLS

ABOUT SIVAKUMAR V. AATHIMANIKANDAN

HIGHLIGHTS:More than 20 years of chemical research/process chemistry development experience, comprising 15+ years of experience in Pharmaceutical Industries, with proven track record of achieving project goals including timely completion of projects.Highly experienced in overseeing multiple projects and leading a team of chemists to execute and complete the project goals in a timely fashion.Strong background in identifying and performing cost effective, robust multi-step synthetic routes for complex intermediates and Active Pharmaceutical Ingredients, in manufacturing scales, used in pre-Clinical through Phase stage.Prepare gram to multi kilogram quantities of APIs, intermediates, and reference standards under GLP and cGMP guidelines.Extensive experience in process chemistry research & development and technology transfer of process to Pilot plant under cGMP and non-GMP guidelines (Up to 500 gallon reactors).Extensive experience in synthesizing APIs, with desired morphology for formulation, to meet ICH and FDA regulations, and for the IND submission. Experienced in performing Process Validation and Qualification in accordance with FDA guideline including process evaluation, vendor qualification, process and cleaning validationExtensive experience in developing synthetic routes with telescoping procedures to avoid tedious column chromatography which leads to time and cost effective robust process.Thorough knowledge and understanding of chemical reactions and reaction mechanism and practically employ in chemical synthesis and process research.Experienced in reviewing and/or authoring CMC section for regulatory submissions such as IND and NDA.Excellent written and oral communications, leadership and supervisory skills.