- Ph.D., Physical Chemistry, Massachusetts Institute of Technology (MIT), 2002
- B.A., Chemistry, Vanderbilt University, 1995
- Phi Beta Kappa and Omicron Delta Kappa
- Barry M. Goldwater Foundation Scholarship, Goldwater Excellence in Education Foundation, (1994)
- American Association of Pharmaceutical Scientists—AAPS
- American Chemical Society—ACS
Jason Clevenger, Ph.D., is a principal scientist and director of the Biomedical Engineering & Sciences practice at Exponent. He has over 20 years of experience in medical devices, pharmaceuticals, and advanced materials. He specializes in materials characterization, pharmaceutical CMC consulting, medical device failure analysis, and combination drug/device product development across regulated life sciences industries.
Dr. Clevenger's expertise focuses on materials characterization and process development for specialty manufacturing, with a particular emphasis on products regulated by the U.S. Food and Drug Administration, such as medical devices, combination products, and pharmaceuticals. Dr. Clevenger's physical chemistry experience is applicable to problems involving materials such as semiconductors, MEMS, metal films, dielectrics, polymers, materials processing, materials characterization, pharmaceutical process chemistry, identification of trace contaminants including organics and particulates, and corrosion processes.
Medical devices, combination products, and pharmaceuticals consulting
Dr. Clevenger's medical device experience includes method development for regulatory submissions, product development and manufacturing support, and technology due diligence assessment. His pharmaceutical experience includes process development and optimization for transdermal and solid oral formulations, regulatory compliance and CMC (Chemistry, Manufacturing, and Controls) related issues involving root-cause analysis, corrective and preventive action plans, and quality assurance. He also has experience in the development of combination drug/device products, as well as litigation matters involving patent infringement, contract manufacturing, and business disputes for regulated products.
Materials characterization for advanced manufacturing
Dr. Clevenger's materials characterization background encompasses a broad range of advanced technologies and techniques, with applications in biomedical, semiconductor, and consumer electronics manufacturing. He has extensive experience with plasma chemistry and spectroscopy, thin film metrology and reliability, high-vacuum technology, and semiconductor processing, as well as the following analytical capabilities.
Analytical capabilities
- Laser spectroscopy
- X-ray photoelectron spectroscopy (XPS)
- Auger spectroscopy
- Raman spectroscopy
- Fourier-transform infrared spectroscopy (FTIR)
- Solid/liquid-nuclear magnetic resonance (NMR) spectroscopy
- Gas and liquid chromatography (GC/LC) with mass spectrometry (MS)
- Optical emission/absorption spectroscopy
- Energy dispersive spectroscopy (EDS)
- White-light interferometry
- Spectroscopic ellipsometry
- Atomic force microscopy (AFM)
- Secondary-ion mass spectrometry (SIMS)
Government life sciences investigations
Dr. Clevenger has participated in a variety of government investigations involving life sciences companies and regulated products, including those involving FDA and the Department of Justice under the False Claims Act. He has conducted site visits at manufacturing facilities in the U.S. and Europe to facilitate investigations.
Process development for manufacturing and R&D
Dr. Clevenger has applied his experience in applying process development tools such as Design of Experiments (DoE) for challenging, multi-factorial problems related to semiconductor, consumer product, and medical product manufacturing. He has performed a number of site visits to manufacturing facilities in North America, Europe, and Asia for mitigation of quality deviations and due diligence investigations.
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