Candidate should have thorough knowledge of method development , impurity profile, chiral chemistry, elucidation of organic impurities / genotoxic impurities and degradation products in drug substance using LC-MS-MS, GC-MS, NMR, can Interpret structures, can evaluate chemical synthetic schemes, good with writing technical report drawing chemical structures using ISIS / Chem Draw.
Should demonstrate hands on experience for operation and troubleshooting on Ion chromatography, LC-MS, GC-MS, CAD, Light scattering and Nitrogen detector. Exposure on DSC, TGA, XRD & wet analysis is an advantage.
Candidate should have thorough knowledge on method validation, current ICH guidelines and answering regulatory queries from US/EU/JP FDA regulatory authorities.
Candidate should have 6-8 year experience in analytical research from a repute API research Pharmaceutical Company. Can handle team of 6-10 researchers. (if Ph.D then 6 yrs exp. otherwise 8-10 yrs)
Qualification M.Sc./Ph.D. in Organic Chemistry or Analytical Chemistry