Category
Regulatory, Quality and Clinical
Description
Experience in the biopharma industry with hands-on experience in analytical method development for biopharma products particularly for biosimilar MabsExposure in analytical method development using various analytical tools such as HPLC, UPLC, Ion Chromatograph, Capillary electrophoresis system.Hands-on experience of using various analytical tools such as HPLC, UPLC, Ion Chromatograph, Capillary electrophoresis system would be preferableExperience of Various cell lines in development of in-vitro bioassay methodologies for biosimilar mabs .Anti-proliferation assays, ADCC assays, receptor binding assays in cell-free and cell-based assays and hands on experience using Biacore and FACS system for functional assays.Exposure to various regulatory guidelines for bioassay method development and method validation would be an added advantage.Experience on analytical method qualification and documentations skills. Grade: Executive Officer/ Assistant Manager Experience: 3-8 YearsQualification: M.Sc-Microbiology/Biotechnology/Biochemistry