Chicago, Illinois, United States
Technical product development with broad experience in infectious disease diagnostics. Developed and supported immunoassays for HIV, HCV, HBsAg, HBc, HTLV, Chagas, and SARS-CoV-2. Developed novel biomarker assays for detection of traumatic brain injury in conjunction with US Dept of Defense. Strategic leadership for immunoassay development of biologic products. Extensive experience with design control and FDA submissions. Developed and managed comprehensive project/program budgets and milestones. Management of scientists and engineers in integrating reagent and system development. Scientific leadership of Core Research and Development area including discovery and prototype development of hepatitis, retrovirus, cancer, cardiovascular, metabolic and endocrine assays. Manufacturing Operations leadership roles responsible for on-market technical support, design changes, regulatory submissions, Six Sigma process improvements, and Quality System implementation. Specialties: R&D strategic leadership, immunoassay design & development, core research & discovery, clinical design & execution, and FDA submissions.
Immunoassay prototyping, development and scientific innovation. Managed DoD funded, cross-divisional collaboration program for TBI assay development on POC and Core Lab technologies. Developed multiple serological assays for SARS-CoV-2. Commercialized next generation infectious disease, COVID and TBI lab tests.
Responsible for portfolio management, external Center of Excellence program, and financial/long range plan. Managed shared R&D services including Quality Engineering, Specimen Bank, Clinical Services, and Regulatory Submission groups. Launched two new assays on PRISM blood screening technology.
Management of product development and operations support functions for PRISM blood screening technology.
Technical product development and support for Lake County Operations including over 200 products and multiple instrument systems.