Expert Details
Technical Problem-Solving for Materials and Processes
ID: 107647
Minnesota, USA
Expert has developed numerous methods based on chromatographic separations. Methods have been developed for analytes in both environmental and biological matrices, as well as active ingredients in various formulations. These methods have reliably determined analytes at the part-per-million, part-per-billion, and even part-per-trillion levels. His method for determining formaldehyde in environmental samples has been published by the US EPA as Method 8315.
Expert has many years of experience in troubleshooting HPLC systems and methods. He can diagnose both mechanical instrument and chemical method problems and make repairs or corrections as necessary. He has developed and presented training courses on chromatography troubleshooting.
Skilled in all aspects of quantitative analysis, Expert is an expert in determining trace levels of impurities, active ingredients (major percentage), and complete characterization (mass balance) of formulations. He has used chromatographic, spectroscopic, and wet chemistry techniques.
A significant portion of Expert's career has been devoted to experimental design. He has published articles on application of experimental design strategies for optimizing analytical methods. He has studied the application of design of experiments (DOE) in gas chromatography, liquid chromatography, and supercritical fluid extraction.
Expert is knowledgeable of all areas of supercritical fluid extraction (SFE). He has published and presented results on the application of SFE to extraction of dioxins, PCBs, pesticides, amines, hydrocarbons, and phthalates. He has determined these analytes in soils, waters, feeds, and plastics.
As part of his method development experience, Expert is adept at designing procedures for effectively removing components of interest from sold samples.
Expert has extensive experience in all aspects of analytical chemistry, with an emphasis on organic-analytical techniques. He has taught analytical chemistry courses at the college and graduate level, developed training courses for laboratory staff, managed technical analytical groups, and consulted with a wide variety of industries on numerous topics.
Expert has developed numerous extraction procedures in his work as an analytical chemist. He also develops and presents training courses on sample preparation.
The correct answer to an analysis problem only results when you choose the correct technique. Expert’s extensive experience in a variety of techniques (separations: HPLC and GC; SFE/SFC; FTIR; SEC/GPC; SEM; etc.) allows him to select the most appropriate analytical approach. The solution to most problems should start with the question, "What is the problem?"
Expert has considerable experience helping medical device manufacturers develop and market their products. Device development activities have included: materials selection for components; materials characterization and extractables testing; design of shelf life experiments; and preliminary feasibility testing. Expert also participates in the regulatory approval process, including: preparation of technical data and literature summaries; review of submissions; and technical writing and reviewing. Once the product is in production, Expert assists in optimizing processes, designing process validation experiments, and solving production problems.
Expert wrote and edited technical documentation, technical summary, characterization, risk assessment, literature review, etc., in support of submission by medical device manufacturers for CE marking. CE marks were awarded to each manufacturer.He assisted a manufacturer in understanding the cause of plastic component field failures. He coordinated analytical testing, interpreted results, suggested failure modes and worked with a multi-disciplinary team.He reviewed analytical capabilities and QC program for a major gas manufacturer. Expert recommended technology changes as well as philosophical changes in the entire QA/QC program.He provided on-site training to customers in pharmaceutical, food, and testing industries. He customized his presentations to meet the needs of individual laboratories.He provided expert advice to a law firm representing a medical device manufacturer in a patent infringement suit. He reviewed testing and reports, and prepared for trial testimony. The case was settled pre-trial in favor of the medical device manufacturer.
Education
Year | Degree | Subject | Institution |
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Year: 1982 | Degree: Ph.D. | Subject: Organic-Analytical Chemistry | Institution: Iowa State University |
Year: 1976 | Degree: B.S. | Subject: Chemistry | Institution: University of Wisconsin, River Falls |
Work History
Years | Employer | Title | Department |
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Years: 1993 to 2001 | Employer: Undisclosed | Title: President/Consultant | Department: Undisclosed |
Responsibilities:He provides consulting and independent contractor services and works with the development and presentation of technical staff training seminars. |
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Years | Employer | Title | Department |
Years: 1985 to 1988 | Employer: Undisclosed | Title: Principal Research Scientist | Department: Undisclosed |
Responsibilities:Expert was the project manager in the analytical chemistry department for both industrial and government clients. He was the Group Leader for the HPLC section. |
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Years | Employer | Title | Department |
Years: 1982 to 1985 | Employer: SUNY - Buffalo | Title: Undisclosed | Department: Chemistry Department |
Responsibilities:He prepared grant proposals, directed undergraduate and graduate research, and taught analytical chemistry courses at the undergraduate and graduate level. |
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Years | Employer | Title | Department |
Years: 1997 to 2000 | Employer: Undisclosed | Title: Technical Director | Department: Undisclosed |
Responsibilities:Expert reviewed technical characteristics for GMP production of medical devices and development of new devices. He also wrote and edited technical and regulatory submissions, optimized processes and solved processing problems, and coordinated clinical complaints. |
International Experience
Years | Country / Region | Summary |
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Years: 1999 to 1999 | Country / Region: Guam | Summary: He delivered customized training seminars at an analytical laboratory. |
Years: 1997 to 2000 | Country / Region: The Netherlands | Summary: Expert worked with the staff at a facility for manufacturing medical devices. He reviewed procedures, evaluated new projects, and suggested testing programs and technology options. |
Career Accomplishments
Associations / Societies |
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Expert is a member of the American Chemical Society, the Minnesota Chromatography Forum, and the Association of Consulting Chemists and Chemical Engineers. |
Professional Appointments |
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He is on the Governing Board of the Minnesota Chromatography Forum. Expert is also a Member, and is on the Scientific Advisory Board, of Novamed Medical Manufacturing Corporation. |
Awards / Recognition |
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He is listed in Who's Who in America. |
Publications and Patents Summary |
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Expert has more than 20 publications and has given more than 30 presentations at local, national and international meetings. |
Additional Experience
Expert Witness Experience |
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Expert has given two depositions. At one, he was an expert witness on waste stream composition. At the other, he was an expert witness regarding chemical characterizations. |
Training / Seminars |
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He has taught the "Practichem" series of training seminars. The series includes the following courses: Analytical Laboratory Techniques; Practical Laboratory Statistics; Analytical Calibration Techniques; Sample Preparation; Troubleshooting Chromatographic Systems; and Advanced Topics in Chromatography. |
Vendor Selection |
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He has provided support for clients needing the following: HPLC equipment, GC equipment, gas analyzers, and supercritical fluid systems. |
Marketing Experience |
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Expert assisted medical device manufacturers in obtaining regulatory approval. He prepared and/or reviewed their technical publications in support of products. |
Other Relevant Experience |
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He wrote a Windows-based software program for chemistry application and developed a laboratory clip art collection. Both items have been sold through a software distributor. |
Fields of Expertise
chromatography data analysis, chromatography method development, high-performance liquid chromatography troubleshooting, liquid chromatography, quantitative chemical analysis, design of experiments, supercritical fluid extraction, solid extraction, analytical chemistry, chemical analysis extraction, analysis technique, biomedical device, volatile organic analysis, forensic chemistry, high-performance liquid chromatography detector, statistical design of experiments, analysis of variance, assay development, organic chemical separation, supercritical carbon dioxide extraction, analytical test, analytical testing, derivatization, analytical chemistry instrument, chemical instrument, biomedical application, plastic medical device, analyte, high-performance liquid chromatograph, reverse-phase chromatography, central composite design, statistical degree of freedom, capillary gas chromatography application, capillary gas chromatography, supercritical gas extraction, process design variation reduction, organic compound qualitative analysis, organic compound quantitative analysis, chromatography data handling system, chromatography data acquisition, size-exclusion chromatography, hazardous chemical analysis, supercritical fluid chromatography, high-performance liquid chromatography, analytical reagent, response surface methodology, supercritical fluid, trace analysis, statistics, simplex method, process chemistry, process optimization, medical device, implantable device, gas chromatography, chemical analysis