Greater Indianapolis
Scientist/manager with experience leading teams of scientists and laboratory analysts. Technical skills include large molecule characterization, biopharmaceutical impurity analysis, immunochemistry, and drug target identification. Soft skills include people/project leadership, client management and business development. Current and previous projects have included development and GxP validation of large molecule identification, purity, and content methods, as well as biodistribution (BioD), vector shedding (by qPCR and RT-qPCR), pharmacokinetic (PK) and anti-drug antibody (ADA) assays, design of immunogens for monoclonal antibody production, and compound screening for use as protein aggregate diagnostics and enzyme inhibitors. Especially interested in how both small molecules and biologics, such as recombinant proteins and monoclonal antibodies, can be used to modulate target behavior in the context of disease. Specialties: Biopharmaceutical Quality Control Methods, Immunochemistry Studies, Gene and Cell Therapy Methods, Biodistribution and Vector Shedding, Pharmaceutical Research, Disease Target Identification, Project Leadership, Mechanistic Enzymology, Protein Characterization, Biochemical Assay Development, Monoclonal Antibody Immunogen Design
Responsible for the development and validation of quantitative (PK) and semi-quantitative (ADA) ligand-binding/immunoassays (LBA) to support large molecule bioanalysis of pre-clinical and clinical trial samples. Currently serving as interim group leader of the LBA team.
Responsible for the scientific, technical and GMP regulatory conduct of assigned client-sponsored studies within the Covance Biopharmaceutical Chemistry, Manufacturing and Controls (CMC) Solutions department in Greenfield, IN. Duties include the creation of study protocols, interpretation and approval of study data, and documentation and reporting of results.
Responsible for the overall scientific and regulatory (GLP/GCP) conduct of pharmacokinetic (PK) and immunogenic (ADA) pre-clinical and clinical trial bioanalytical (BioA) studies. Leads a team of laboratory analysts and method developers that perform large-molecule ligand binding assays. Supervises the work of study coordinators to produce study protocols and reports. Fosters relationships with pharmaceutical company study sponsors to ensure that their needs are met and that Covance revenue goals are achieved.
Lead monoclonal antibody development project teams in the areas of neurodegenerative disease and synaptic function. Designed protein target immunogens, evaluated usage modalities for new antibodies, presented educational webinars internally and to customers, and provided scientific leadership to the Antibody Products group.