Rajendra Kankati

About Rajendra Kankati

A highly motivated and accomplished leader with a demonstrated history of working in the pharmaceutical industry specialized in drug substance and drug product analysis in cGMP environments. Comprehensive knowledge of analytical chemistry in method development and validation for drug product and drug substances. Thorough understanding of the pharmaceutical development process, quality by design (QbD) principles, FDA regulations/guidance\'s and ICH guidelines. Strong research professional with a Doctor of Philosophy (Ph.D.) focused in Chemistry. Possess strong leadership/supervisory, organizational, communication and interpersonal skills and is open for a challenging opportunities.Technical Skills:• Proficient in Chromatographic/Spectroscopic techniques like GC, GC-MS, HPLC/UPLC, LC-MS, UV/VIS, FTIR and NMR and well versed with chromatographic software. Over 15 years of experience in analytical method development, validation, data analysis, troubleshooting and problem solving skills. Command in analytical chemistry, organic chemistry, structural elucidation, impurity identification and well exposure to protein chemistry. Developed methods for Genotoxic impurities (GTIs).• Handled multiple projects, conducted analytical experiments for optimization, troubleshooting, modification and to address FDA requirements/deficiencies of analytical methods for APIs and drug products. Write detailed scientific reports, analytical test methods, protocols, validation reports and product justification reports for ANDA/NDA submissions and supported PAI inspections. Designs and coordinates method transfer to other departments and to or from external vendors and CROs.

Experience

1. Director, R & D-ad Team Lead

   Nevakar Pharmaceuticals

   Jun 2021 — Present · NJ, US

Education

• Osmania University

  Doctor of Philosophy (Ph.D.), Chemistry