Derek Toth

Sr Director - Bio Analytical Development and Validation @Emergent BioSolutions

Overall responsibility for development and validation analytical and bioanalytical assays for characterization, in-process, product release assays for cGMP for licensed products (FDA, Health Canada, EMA). GLP Test Site Manager, responsible for management oversight of Bioanalytical Testing (PK ELISA, PK Bioassay, Biomarker, Immunogenicity) for GLP/GCP studies In-depth knowledge and experience with OD/Fluorescence based microplate readers (Molecular Devices), Mesoscale discovery electrochemiluminescence, and Biacore. Leadership in the development and validation of in-vitro cell based bioassays, ELISAs, and Immunoligand (ILA) assays for product release/stability testing in a cGMP environment as well as assessing immunogenicity & biotherapeutic drug levels in preclinical/clinical development cGLP/cGCP environment. Responsible department with 30+ scientific professionals on a daily basis providing efficient support to various projects including cross training and performance reviews.