Expert Profile
Analytical Professional with experience in sterile injectable cGMP manufacturing investigations, forensic laboratory design and implementation for cGMP applications, and forensic evidence analysis. Expertise includes particle and drug analysis, GC/MS, SEM/EDS and investigation management. Noted for the following:
• Exceptional oral and written communication skills honed through writing technical reports, SOPs, and courtroom expert witness testimony
• Strong leadership skills, sense of teamwork, and desire to mentor
• Proven ability to effectively prioritize work and lead multiple, concurrent projects in a timely and professional manner
***** SOLUTIONS, LLC- Newton, MA
Owner/Founder March 2011- Present
• Established ***** Solutions, LLC to support the pharmaceutical industry in the scientific evaluation of particulate contaminants. Areas of expertise include investigation management, laboratory design, implementation and validation, training, and expert interactions with regulatory agencies related to foreign matter analysis.
GENZYME CORPORATION- Allston, MA
Principal Analyst, Quality Control June 2010- June 2011
Senior Analyst, Quality Control April 2009- June 2010
Analyst II, Quality Control April 2007- April 2009
• Developed and established a forensic-style analytical laboratory for foreign matter and manufacturing investigations within a sterile injectable cGMP facility under Consent Decree. The development process included all aspects of laboratory design such as establishing user requirements, change control procedures, instrument search and price negotiations, and laboratory infrastructure changes.
• Assist with written and oral responses to regulatory agency findings related to foreign matter contamination.
• Purchased and validated an FTIR microscope and SEM/EDS for the QC laboratory. Authored SOPs for the new instrumentation and developed a training curriculum for the particle analysis program. Trained four analysts within the curriculum.
• Expanded the foreign matter analytical capabilities to support investigations for additional sterile injectable manufacturing sites in the US, Ireland and Belgium. Initiated the development of an additional analytical lab at the Ireland facility using the system established in Allston.
• Analyze particulates submitted from customer complaints and investigate sources of contaminants. Support manufacturing investigations of unknown materials.
MONTANA STATE CRIME LABORATORY- Missoula, MT *****
Forensic Scientist, Chemical Analysis Unit
• Analyzed controlled substances, clandestine drug manufacturing evidence, and arson evidence using GC/MS, FTIR and Raman spectroscopy, and SEM/EDS.
• Testified numerous times as an expert witness. Assisted law enforcement and prosecutors with investigations and court preparation.
• Assisted with quality improvements to the crime lab to achieve accreditation by the American Society of Crime Lab Directors (ASCLD), the leading accreditation agency for crime labs nationwide.
INDIANA UNIVERSITY SCHOOL OF MEDICINE-Indianapolis, IN Feb. 2001- Oct. 2001
Research Assistant, Department of Endocrinology
• Assisted with a genetic research study of metabolic bone diseases to support published research.
QUEENSLAND POLICE SERVICE-Brisbane, Australia 1998 – 2000
Forensic Scientist, Chemistry Unit
• Analyzed trace evidence such as fire debris and paint employing GC/MS and SEM/EDS.
• Prepared statements for court and assisted law enforcement and prosecutors with investigations and court preparation.
• Published a study on how the composition of plastic bags used to store arson evidence could negatively affect the analysis.
US SECRET SERVICE-Washington, DC 1997 – 1998
Research Intern, Forensic Science Division
• Researched the chemistry of latent fingerprints under the guidance of Dr. Antonio Cantu, a renowned expert in the field. Projects included the study of lipid components in latent fingerprints, and the study of ninhydrin analogs for the development of fluorescent fingerprints.
PIERCE COUNTY MEDICAL EXAMINER’S OFFICE-Tacoma, WA 1995 – 1997
Forensic Associate
• Assisted with forensic autopsies, collection and preservation of evidence, photography, and the presentation of evidence in courts of law.
• Developed the curriculum and the standards for the student internship program and supervised the education and progress of the interns. Taught interns and visiting students how to perform an autopsy, collect evidence and take photographs.
• Prepared and delivered seminars to hospital staff, police departments and fire departments on the relationship between forensic pathology and traumatic injury.
THE GEORGE WASHINGTON UNIVERSITY – Washington, DC *****
Master’s degree in Forensic Science
UNIVERSITY OF PUGET SOUND – Tacoma, WA
Bachelor of Arts in Biology *****
ADDITIONAL TRAINING
Microscopical Identification of Pharmaceutical Materials and Contaminants. McCrone College of Microscopy. Westmont, Illinois. August, 2009.
Microscopic Particle Handling: Particle Isolation, Manipulation and Mounting. McCrone College of Microscopy. Westmont, Illinois. October, 2008.
Advanced Fire Debris Analysis School. Hosted by the National Center for Forensic Science. Augusta, Maine. September, 2005.
Basic Fire Debris Analysis School. Hosted by the Bureau of Alcohol, Tobacco, Firearms and Explosives. Ammendale, Maryland. August, 2005.
Analysis of Samples from Clandestine Methamphetamine Laboratories. American Academy of Forensic Sciences meeting. New Orleans, Louisiana. February, 2005.
Forensic Investigation of Clandestine Laboratories. Northwest Association of Forensic Scientists meeting. Missoula, Montana. April, 2004
DEA Forensic Chemist Seminar. Forty hour course taught by members of the Drug Enforcement Administration. Sterling, Virginia. December, 2003.
Mass Spectral Interpretation and MS Applications in Forensics. Northwest Association of Forensic Scientists Meeting. Portland, Oregon. October, 2003
Clandestine Laboratory Workshop: Determining production Capacity. Northwest Association of Forensic Scientists meeting. Portland, Oregon. October, 2003.
Training in the analysis of marijuana, powdered drugs, opiates and steroids. Montana State Crime Laboratory. July-September 2003.
PUBLICATIONS
Waguespack SJ, Koller DL, White KL, Fishburn T, Carn G, Buckwalter KA, Johnson M, ***** MJ, Evans WE, Foroud T, and Econs MJ. Chloride Channel 7 (ClCN7) Gene Mutations and Autosomal Dominant Osteopetrosis, Type II. Journal of Bone and Mineral Research 2003; 18:*****.
***** MJ. Absorption of ignitable liquids into polyethylene/ polyvinylidine dichloride evidence bags. J Forensic Sci 2001; 46(2)*****.