Experienced bioanalytical group leader with 20 years total experience, 15 years in GMP setting. Well versed in FDA and ICH assay validation guidelines. Authored drug substance and drug product comparability studies for programs from Phase 1 to Phase 3 clinical trials. Broad experience in protein bioanalytical methods and biochemical assays.Specialties: Hands-on and supervisory experience with mass spectrometry (Q-Tof and MALDI), HPLC (RP, HIC, IEX and SEC), circular dichroism, light scattering (static and dynamic), capillary electrophoresis, DNA detection (Threshold and PicoGreen), ELISA, gel electrophoresis (SDS-PAGE, IEF, 2-D and western blotting), bioassays, HTS systems and fluorescence technologies (FP and FRET).
Listed skills include Hplc, Elisa, Sds Page, Mass Spectrometry, and 5 others.