Experienced biochemist who has validated enzyme and immunoassays to CLIA regulations for routine diagnostic testing, and sponsor-specific assays for GLP studies. Knowledgeable in all phases of assay development, from analyte sourcing, feasibility studies, validation, implementation, and transfer to technical staff. Subject matter expert for responding to regulatory requests regarding bioanalytical methods. Comfortable working and communicating in multidisciplinary project environments. Considerate to the comments and ideas of team members in individual and group settingsSpecialties: 10+ years experience in the biotech industry:cGLP certified;cGMP certified;commercialization of laboratory developed tests;immunoassay development and validation;supervision of research associates;training of medical technologists;chromatographic system expertise (low- and high pressure systems);enzyme kinetics and characterization.