Industry Consultant (Former FDA)

EDUCATION

• Bachelor of Science in Forensic Science,

EASTERN KENTUCKY UNIVERSITY, Richmond, KY - August 1988

PROFESSIONAL EXPERIENCE

U.S. FOOD & DRUG ADMINISTRATION, FORENSIC CHEMISTRY CENTER, Cincinnati, OH

Trace Analyst – Trace Examination Section (TES) (03/16/2020 – 4/30/2021)

Responsibilities involve using optical microscopy and vibrational spectroscopic instrumentation (macro- and micro- spectroscopic infrared techniques) and related methods (visual analysis) for forensic investigations that deal with compromised FDA regulated products resulting from tampering, counterfeiting, adulteration and/or product diversion.

U.S. FOOD & DRUG ADMINISTRATION, Florida District Office, Maitland, FL

Consumer Safety Officer – Biomedical Research Monitoring (04/18/16 – 03/15/2020)

Responsibilities involved conducting inspections of clinical investigators conducting studies on human subjects and animals. These inspections include the insurance that the studies maintain regulatory compliance and that they meet all regulatory requirements. These audits include clinical investigations, Institutional Review Boards, Sponsors, and Bioequivalence studies which include sampling and review of scientific procedures.

U.S. FOOD & DRUG ADMINISTRATION, FORENSIC CHEMISTRY CENTER, Cincinnati, OH

Trace Analyst Expert – Trace Examination Section (TES) (07/28/02 – 04/17/16) 

Responsibilities involve using optical microscopy and vibrational spectroscopic instrumentation (macro- and micro-spectroscopic infrared techniques) and related methods (visual analysis) for forensic investigations that deal with compromised FDA regulated products resulting from tampering, counterfeiting, adulteration and/or product diversion.

TES Supervisor Detail (12/02/12 – 01/27/13) (GS14-4) and (2/25/14 – 4/5/14) 

In addition to the responsibilities as the Trace Analysis Expert where managing the TES section (eight employees), reviewing case work, case sample summary reports, managing the case load, attending FCC supervisory meeting and coordinating work between the separate sections within the FCC.

Chemist- Inorganic Branch (2/25/1990 – 07/28/2002)

Responsibilities involved using inductively coupled plasma with atomic emission spectroscopy to conduct analyses for forensic investigations that deal with compromised FDA regulated products resulting from tampering, counterfeiting, adulteration and/or product diversion. Also, during this time responsibilities were transitioned to the microscopy section which involved optical microscopy and vibrational spectroscopic instrumentation (macro- and micro-spectroscopic infrared techniques) and related methods (visual analysis) for forensic investigations that deal with compromised FDA regulated products resulting from tampering, counterfeiting, adulteration and/or product diversion.

PINELLAS COUNTY CORONERS OFFICE, Largo, FL

Forensic Chemist (August 1988 – February 1990)

Responsibilities involved using gas chromatography with mass spectrometry, optical microscopy and vibrational spectroscopic instrumentation macro-spectroscopic infrared techniques to identify drugs of abuse for the county.

PROFESSIONAL ACCOMPLISHMENTS

A full list of publications and presentations is available upon request.

Career with the Forensic Chemistry Center, resident expert in the analysis of the following: Optical microscopy coupled with micro-spectroscopic infrared techniques, botanical identifications, microchemical analysis of organic and inorganic compounds, multi-component samples (e.g. dietary supplements, combination drugs, etc.), blood and other body fluids, fibers, drugs, tool-mark analysis and tampering samples.

Author of Standard Operating Procedures (SOPs)

1. SOP E172: Optical Microscopy (2013)

2. T008: Particle Handling Procedures for the Trace Examination Section. (2014)

Noteworthy Expert Witness Testimony

1. Tacoma, Washington, September 17, 2013. Tampering case that required the examination of antibiotic eye drops for the presence of sodium hypochlorite (bleach). A mother was accused of repeatedly administering eye drops adulterated with bleach to a 14-month old child. The defendant was found guilty of first-degree child assault on October 4, 2013 and was sentenced to 40 years in prison on November 15, 2013.

2. Lufkin, Texas, March 12-15, 2012. A case of a nurse suspected of killing at least four separate patients in a dialysis clinic by injecting the dialysis lines with a solution of bleach. The defendant was found guilty and sentenced to life in prison without parole. This verdict was just upheld by the Texas Court of Appeals January 22, 2014.

3. Yakima, Washington, March 16-19, 2010. A case of a nurse who was substituting water for narcotics used in an area hospital. Defendant was found guilty and prior to sentencing committed suicide.

Additional Accomplishments:

1. Authored or co-Authored 11 external peer-reviewed scientific articles, and 11 internal scientific articles.

2. Presented or contributed to over 40 presentations.

3. Have received over 30 FDA awards and multiple outside awards for work conducted while with the FDA.

4. Testified in over 30 state and federal trials.