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Expert in Analytical Science - Problem Solving, Elastomers, Pharmaceutical, Medical Devices, Generic Drug
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Expert has worked the field of analytical chemistry for over 30 years. His PhD thesis was on phosphorus NMR as a trace analytical tool. He joined Goodyear and both developed analytical methods mainly using HPLC and GC and after 6 years he managed the methods development, spectroscopy (IR, GC-MS, NMR, XRD), and chromatographic analyses. These techniques were applied to elastomeric polymers and compound ingredients, i.e. curatives, accelerators, AOs, and process aids. He joined Abbott Labs where he worked on plant troubleshooting with analytical chemistry and became the Technical Director where he directed the development of elastomeric and thermoplastic components - chemistry, curing, prototyping, and transfer to manufacturing. Applications included drug interactions, extractables, generic drugs, biocompatibility, and USP testing. He also taught a course on Pharmaceutical Rubber Chemistry for pharmacists and analytical chemistry at R&D, Regulatory Affairs, and several of the drug manufacturing plants.
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Expert has been developing analytical test methods for over 30 years. Beginning with his PhD thesis on using phosphorus NMR as a trace analysis tool. Then joined Goodyear and developed over 30 HPLC methods supporting research and commercial programs. He then managed the methods development group which during the following 9 years involved managing the development of an additional analytical methods for IR, NMR, XRD, chromatography, and wet chemistry. Expert then went to Abbott Labs where he developed a custom spectrometer for use as a QC tool for insuring that a plastic cuvette used in a diagnostic medical test met a clarity release test. He also conducted several tests on elastomeric closures (USP 381) and extractable studies on drug packages. His forte is analytical test method development based on chromatograph, spectroscopy, or other techniques. He published an HPLC method on terephthalic aicd with a detection limit of 25ppb in 1980 and a method for nitrosamines in baby bottle nipples in 1998.
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While working at Abbott Labs, Expert was involved with several of the generic drug teams to assist them in the launching of new generic drugs. He conducted reverse engineering studies on competitor's elastomeric closures as well as USP testing to attempt to determine the innovator's elastomeric compound. Most recently he was involved with the evaluation of extractables in the generic drug closure as well as potency studies. Expert was involved with several generic drug teams as the expert on the closure and its related issues.
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Expert has worked with polymers for almost 30 years. He started with elastomers at Goodyear. He has finished several of Goodyear polymer plants to assist in troubleshooting process problems. He also represented Goodyear at the Center for Process Analytical Chemistry at the Univ of Washington where he monitored several research programs focused on developing process analytical chemistry devices with the intent of reducing costs and improving product quality. At Abbott, Expert has done consulting on polymers used in drug packages and medical devices. He also taught a seminar on Pharmaceutical Rubber Chemistry which included a section of rubber chemistry and pharmaceutical compound development.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Columbus, Ohio;
Cleveland, Ohio;
Akron, Ohio;
Youngstown, Ohio;
Canton, Ohio;
Lorain, Ohio;
Lakewood, Ohio;
Elyria, Ohio;
Pittsburgh, Pennsylvania;
and Erie, Pennsylvania.
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| Year |
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Degree |
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Subject |
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Institution |
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Honors |
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1976
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PhD
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chemistry
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Case Western Reserve University
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1968
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BA
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chemistry
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Houghton College
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honors in chemistry
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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2007 to 2007
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US State Department
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Fulbright Program
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Senior Fulbright Research Scholar
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He conducted research at the National Academy of Science - Institute for Single Crystals in Kharkiv, Ukraine on iminocoumarine reactions with acetic anhydride and used HPLC to characterize the reaction products.
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2004 to 2006
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Hospira Inc.
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R&D
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Technical Director
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He managed an R&D group of chemists, engineers, and technicians involved in formulating elastomeric compounds for drug packages - vials and IV bags
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1991 to 2004
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Abbott Laboratories
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Hospital Products
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Technical Director
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He managed an R&D group of chemists, engineers, and technicians involved in formulating elastomeric compounds for drug packages - vials and IV bags
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1991 to 1992
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ICI Americas
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Specialty Chemicals
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Group Leader Separation Science
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He managed a separation science group consisting of 9 chemists and technicians involved with analytical method development and routine chemical analyses.
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1976 to 1991
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Goodyear Tire & Rubber Co
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Research
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Section Head Analytical Methods Development
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He managed a methods development - chromatography and spectroscopy
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Associations/Societies
ACS
PDA
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Professional Appointments
Fulbright Scholar
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| Publications: |
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Publications and Patents Summary
He has 6 publications and is coauthoring a book on azaheterocycles
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Selected Publications and Publishers
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- Journal of the Parenteral Drug Association
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- Rubber & Plastics News - Technical Notebook
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- Analytical Chemistry
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- Journal of Chromatographic Science
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| Government Experience: |
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Agency |
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Role |
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Description |
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2007 to 2007
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US State Department
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Fulbright Scholar
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He conducted research in Ukraine
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| Selected Consulting Examples: |
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He is consulting a contract analytical lab to establish a FDA approved testing facility
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He is consulting with a contract analytical lab specializing in microscopy to expand their business into the area of medical applications
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He is consulting with an international organization to assist in selling commercial chemical processing equipment in the USA
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Recent Client Requests:
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Elastomeric design expert consutants for consulting on Molded Rubber Seal and Bellows Design.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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| Years |
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Country / Region |
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Summary |
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1970 to 1972
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Germany
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He was trained as a German linguist and lived in Berlin and worked for a security service that collected intelligence
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2007 to 2007
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Ukraine
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He conducted research at the Institute of Single Crystals
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| Language Skills: |
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| Foreign Language |
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Description |
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German
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He can understand and speak German with fair proficiency and can read with good understanding
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Russian
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He has an elementary understanding of Russian
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knowledgeable in the drug industry related to drug packaging
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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Training/Seminars
Pharmaceutical Rubber Chemistry
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Education
