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2) He has also been the Responsible Person for a SAMSHA employee drug testing laboratory and Co-laboratory director of a Clinical Toxicology laboratory and can give expert testimony in these fields

2010 to 2010

Franey Medical Laboratories

Laboratory Co-Director

Developed LC-MS-MS method for Ethyl Glucuronide (Biomarker and metabolite of Ethanol). Revised LC-MS-MS method for Buprenorphine, Norbuprenorphine, and Oxycodone. Revised Procedure Manual, Quality Manual, and Safety Manual Served as Co-Laboratory Director and provided Technical expertise resource.

2007 to 2010

First Light Biosciences

Principal Scientist

Nanoparticle reagent optimization using DOE methods for development of Multipath® immunoassay and cellular analysis platform for clinical diagnostics and bioterrorism testing. Providing leadership for assay development and clinical studies for the Multipath® prototype instrument. Participated in grant writing that secured two phase I NIH SBR grants and a large phase II Biodefense grant Drafting patents in support of the company's intellectual property position Participated in document preparation and implementation of all aspects of company FDA QSR system Served as Company Safety Officer. Drafted Informed Consent Forms and interfaced with contracted commercial IRB

to

(Undisclosed)

Chief Scientist

Responsible for formal process of evaluating new biomarkers and technologies for potential new IVD products, and providing scientific leadership. Responsible for evaluating existing scientific and patent literature and drafting patents in support of the company's intellectual property positions. Personal conducted assay development of several particle based homogeneous immunoassay products – Troponin I, Ferritin, and Prealbumin Wrote documents to meet FDA QSR regulations (including Design Control and History, Device Master Records and SOPs) and to meet ISO 13485 standards and EU CE mark requirements Troubleshooting problems in manufacturing and reagent development under FDA Design Control. Conducting and preparing instrument applications and 510(k) add-to-files for Direct TIBC assay and 510(k) submissions for hsCRP and Ferritin immunoassays and calibrators

• Diatech Diagnostics, Boston, MA 1996 -1997 ConsultantResearch to improve production processes for a line of drugs-of-abuse and hormone ELISA assays including management of installation of HPLC system used for both raw material and process evaluation, and improved purification of conjugates used in products.
• Reference Diagnostics - Set-up HPLC system for separation and on-line detection of Lioporotein fractions from Human Serum. Assay and Regeant development

• Expert in Immunoassay constultants for consulting on Immuoassay Development.