Chief Executive Officer
Jim has been an international diagnostics leader for over 25 years; driving creative growth and partnerships with positions in operations, R&D and finance. He was CEO of Orgentec Diagnostika and Sr. V.P. of Commercial Operations at Beckman Coulter. He is Board Chair of the Keck Graduate Institute and holds Bachelor and Master of Engineering degrees from Harvey Mudd College and a MBA from UCLA.
Kelly R. Pitts Ph.D.
Chief Scientific Officer & General Manager
Kelly has a 20-year history in drug and diagnostic discovery, development, and commercialization in companies such as Amgen, Gilead Sciences, and Orgentec Diagnostika. In diagnostics he works with pharma/biotech, diagnostics, government, non-profit, and regulatory entities globally. Kelly holds a BS degree in Biochemistry from BYU and a PhD in Cell and Molecular Biology from Mayo Clinic.
Taryn G. Reynolds
Chief Operating Officer
With over three decades of experience and commitment in the Medical Diagnostic field with experience in areas of Administrative and Operations management, Finance, Human resources, Lean Manufacturing, Quality System development, Information Technology, Cloud & security management, facility design and management, CLIA/CAP lab development, Taryn brings both experience and stability to the management team.
Vice President, Business Development, Personalized Diagnostics
20-Year Personalized Medicine Veteran with a track record of success in Oncology Diagnostic Sales and Marketing (Oncor, Becton Dickinson), Oncology Pharmaceutical Sales (AstraZeneca), Oncology Pharmaceutical Advertising (Palio, FCB, GSW & LLNS) and Companion Diagnostics Business Development (QIAGEN). B.S. Biology, SUNY Stony Brook; M.S. Human Cytogenetics, Hofstra University.
Senior Director of Quality Control and Product Support
30 years’ experience in supporting quality, enhancing product performance and promoting efficiencies through process improvements and design control changes. Developed test methods, statistical analysis and control chart trending. Project manager for contract manufacturing. BS Degree in Medical Technology from Northern Illinois University, School of Allied Health Professions. MT (ASCP) certified.
Daniel F. Simpson, RAC, ASQ CBA
Senior Director Quality and Regulatory Affairs
Seasoned Regulatory and Quality Management System (QMS) professional in the diagnostic (IVD) and medical device sector. Technical background and over 25 years diverse experience in diagnostic and biotech companies. Specializes in unique and innovative approaches to regulatory strategy, product submissions, and QMS compliance in an ever changing regulatory environment.
Senior Director of Sales
Sales and support leader in diagnostics for >25 years. Record for demonstrating an ability to provide strong leadership and execution of business strategies. Degree in Biochemistry, with extensive background in immunoassay development and marketing for research and clinical use. Expertise in business development, market analysis, international distribution and managing support teams.
Experience with ELISA design and development according to Design Control per FDA and ISO requirements. Background includes project management, verification and validation activities, risk management, and transfer into production for product fulfillment. Technical resource for Quality, Regulatory and Customer Support. Bachelor of Arts in Biology from the University of Texas at Austin.
Amandla Atilano-Roque, PhD
Clinical Research Scientist 1
Translational researcher with a background in Toxicology. Experienced in wet-lab, molecular biology, and clinical operations. Responsible for managing the clinical monitoring process and administration of clinical projects. Passionate about science education, training, and clinical innovation. University of Colorado Anschutz Medical Campus PhD.
Worked in accounting and finance since 1996. Oversight of all accounting and financial activity and human resource functions at Corgenix maintaining controls and accuracy. Strong financial reporting and analytical skills to keep leadership abreast of performance. Bachelors earned 1995 from CSU and Masters in Accounting and Financial Management in 2015 from Keller Graduate School.