Bio

• SME in analytical method development and qualification/validation of analytical assays using qPCR, ddPCR, ELISA, HPLC, ddPCR etc. for gene therapy drug substance and drug products. • Familiar with cGMP principles and regulatory (ICH, USP, FDA) guidelines. • Experienced in managing assay development activities at CDMO and CTL and CRO. • Management of analytical support for in-house process development and manufacturing activities. • Experienced in developing a variety of protein/Enzyme-based colorimetric, fluorometric, luminescence, FRET, TR-FRET, Fluorescence Polarization/Anisotropy assays for RUO product development. • Building teams and leading cross functional teams in managing variety of cross functional projects.