| Analytical/Pharmaceutical Science Consultants |
A consulting firm committed to providing technical support & problem solving in the areas of:
– Analytical Science
– Elastomers/Polymers
– Pharmaceutical and Medical Device Applications
– Industrial Applications
Thomas Gurley, Ph. D.
BACKGROUND:
30+ years as a highly productive professional chemist including:
– Developed new analytical test methodology to solve practical problems
– Applied chromatographic techniques to solve industrial problems
– Managed the development of over 200 analytical methods
– Support to Generic Drug programs – material science and analytical chemistry
– Developed new elastomeric compounds for pharmaceutical applications
– Converted medical products from latex to synthetic polyisoprene compounds
– Managed analytical method development laboratories
– Provided analytical consulting
ACCOMPLISHMENTS:
*Awarded a SBIR grant by the US Army for the development of a non-microscopic method of analysis to detect malaria in blood
* Awarded a Fulbright Senior Research Scholarship to conduct research at the National Academy of Science Ukraine at the Institute of Single Crystals on microwave-assisted chemical synthesis of acetylated iminocoumarines using HPLC and NMR
– Awarded trade secrets for an improved probe for FORS measurement of viscous materials and a gas permeation analyzer for measuring permanent gas permeation through polymer films
Managed the development of rubber injection-compression molding technology for the production of pharmaceutical elastomer closures and IV set components
– Recommended process analytical solution to environmental wastewater problem and assisted in installing analyzer to measure vinyl chloride in wastewater using process GC
– Coordinated the conversion of several pharmaceutical and consumer products from rubber compounds containing natural rubber to a synthetic polyisoprene equivalent material
– Develop a diode array/fiber optic based clear acrylic multicuvette analyzer as a QA tester for production of the cuvettes to insure optical clarity and equivalency of the product
– Initiated process analytical process program including Center for Process Analytical Chemistry sponsorship, purchase of 5 process analyzers i.e. NIR and fiber optic remote spectroscopy (FORS)
– Demonstrated the application of FORS – fiber optic remote spectroscopy- (grating and diode array technology) for monitoring polymerization catalyst levels, determining %polymer solids in polymer cement, measuring acrylonitrile in an aqueous recycle stream, monitoring molten (250ºC) PET, and tracking uniformity of rubber mixing in an extruder
– Developed NIR reflectance and transmission methods for measuring polymer functional groups, polymer additives, polymer microstructure, silicone in resin, oil in rubber, powdered chemical mixture compositions, and ppm levels of an organic solvent in wastewater
Education
– PhD, Analytical Chemistry, Case Western Reserve, Cleveland, OH 1976
– BA, Chemistry, Houghton College, Houghton, NY 1968
– Attended several Gordon Research Conferences in the 1980s – Analytical Chemistry & Separation Science as well as Pittsburgh Conference.
– Attended Polymer Morphology course coordinated by RPI in New Orleans 1993
– Attended Gordon Research Conference on Elastomers New London NH 1995, 1999
– Attended Analysis of Polymers, University of Twente, Enschede, Netherlands, 2002
– Attended Heal Ohio, Wound Healing Consortium, Akron, OH October 2008
Current Employment
2007:
– President and Founder Manning Wood, LLC, Uniontown, OH
– consulting clients include contract analytical labs and several healthcare/ pharmaceutical companies
– part-time Sr. Lecturer at the University of Akron, Department of Chemistry, teaching General, Organic, and Biochemistry to pre-nursing students
– part-time Adjunct Prof at Kent State University – Stark, Department of Chemistry, teaching General Chemistry
– Professional Activities
– American Chemical Society member
– Parenteral Drug Association member
Employment
Technical Consultant Manning Wood LLC Awendaw, SC 2014- present
Consulted for several companies related to analytical chemistry – medical and water treatment industries. Taught chemistry labs at College of Charleston and Trident Technical C0llege.
Fulbright Senior Lecturer Uganda Christian University 2012-2013 Fulbright Specialist 2013-2018
Set-up a chemistry lab facility and curriculum to teach food and biohemistry in the Agricultural Science department. Taught introductory chemistry class to nursing students. Wrote a chemistry textbook for East Africa. Taught a short course on HPLC analysis of vitamin A in sweet potatoes and shia butter.
Smithers Rapra Inc. Analytical Chemist 2013-2017
manaaged client projects from quote development to lab analysis and final reaper writing. Projects involved the analysis of mainly elastomers and rubber additives. Key analytical techniques used included GCMS, HPLC, ICP, FTIR, AA, and wet chemistry.
S D Myers Inc Analytical Lab Director and R&D Director 2011-2013
-managed an analytical lab consisting of 40 analyst and technicians for the analysis of transformer oil. The lab conducted analyses using HPLC, GC, FT-IR, ICP, and wet chemistry. Conducted R&D on new analytical methods for the characterization of transformer oil including HPLC and GCMS.
Fulbright Senior Research Scholar: Jan- Jun 2007
-coauthored a book with two colleagues from the Institute of Single Crystals in Kharkiv, Ukraine. Aza-heterocycles based on alpha, beta-Unsaturated Carbonyls (Springer Verlag) published October 2008
HPLC and NMR Analysis of Heterocyclic Amines, Institute of Single Crystals, Kharkiv, Ukraine
Abbott Laboratories until May 2004 then Hospira Inc. Technical Director 1996-2006
Direct two groups (15 people) – Polymer Science and Product Development. Provide overall direction for the research and development activities at the plant. Responsible for developing new polymeric materials, products, processes, and supporting existing manufacturing processes.
Manager Rubber Technology 1993-1995
Managed 9 chemists and technicians including the analytical lab. Responsible for development of new rubber products mainly elastomeric closures, stoppers, reseals, baby bottle nipples, sponge, golf ball centers, and hot water bottles. The R&D group supported all production of current products.
Managed the implementation of several conversion programs from natural rubber based compounds to all synthetic polyisoprene compounds for baby bottle nipples and IV elastomeric components. Presented seminar on isoprene polymers synthetic vs. natural. Managed the implementation of rubber injection molding technology for production of pharmaceutical stoppers, syringe plungers, and IV components – sleeves, flashbacks and septa. Coordinated drug closure programs for several generic drug programs at Corporate R&D. Developed program to extrude and cure polyisoprene compound into tubing for use in irrigation surgical sets.
Upgraded the analytical lab with the purchase of a HPLC (DAD) with heart-cutting capabilities into a GC/MSD for characterization of rubber stopper impurities. Solved analytical problems working cooperatively with Corporate R&D. Managed the development of a streamlined GC-TEA method for the determination of nitrosamines in baby bottle nipples. Presented seminars at Corp R&D to analytical chemists and pharmacists on Pharmaceutical Rubber Chemistry and a workshop on Analytical Chemistry of Rubber at Corporate R&D.
Sr. Analytical Chemist 1992- 1993
Managed 2 technicians. Responsible for analytical support for production of rubber and plastic medical and consumer products. Major analytical techniques utilized were chromatography, IR, XRF, AA, and microscopy. Coordinated program to evaluate new thermoplastic elastomeric materials (TPEs) for pharmaceutical applications. Developed new analytical testing instrumentation using fiber optics technology for an acrylic clear multicuvette for blood testing.
ICI Americas, Specialty Chemicals Group Leader, Separation Science 1991-1992
Managed 2 professionals and 6 technicians. Responsible for analytical support to the various businesses within the Corporation.
Goodyear Tire & Rubber Co 1976-1991
Senior Research Chemist, Methods Development (1976-1982)
Developed over 30 new analytical methods for organic chemicals and polymers used in the rubber and chemical industry, trace analysis, air pollutants, wastewater, and FDA required analyses of extractables in polyester beverage containers.
Section Head, Methods Development (1982-1991)
Managed 7-15 professionals- PhDs and technicians. Responsible for developing analytical methods using GC, HPLC, GC/MS, GPC, IC, NMR, IR, NIR, UV, AA, pyrolysis MS, fiber optic UV/NIR, flow injection analysis (FIA), and wet chemistry. These methods were designed for both R&D project support and implementation in plant analytical laboratories for QA analyses.
Major responsibilities as section head included coordinate and direct method development effort; consult/advise technical personnel on analysis problems; keep abreast of current literature to maintain application of state-of-the-art technology; evaluate and recommend purchase of analytical instrumentation, maintain inventory file of in-house analytical methods; perform administrative tasks related to personnel.
Initiated company sponsorship of the Center for Process Analytical Chemistry (CPAC) at the University of Washington, Seattle. Represented the company on the CPAC advisory board. Developed programs and expertise in process analytical techniques – fiber optic remote spectroscopy, near infrared reflectance, chemometrics, FIA, process GC, and pulsed NMR.
MILITARY
US Army Security Agency, German Linguist (West Berlin) 1968-1972
Publications
Books
Aza-heterocycles based on alpha, beta-Unsaturated Carbonyls (Springer Verlag) V Chebanov, S DeSenko, and T Gurley, published October 2008
Journal articles
– Oxygen Permeation and Microbial Ingress through a film coated and uncoated elastomeric closure in a glass drug vial. M Andress, H Dull, T Gurley, T Berger, E Remo, and J Grillo. Journal of the Parenteral Drug Association, 2004, vol 58 (1), pp. 32-44
– Rapid Analytical Method for the Determination of Nitrosamines in Baby Bottle Nipples, M Andress, T Gurley, and S Harsch, Rubber & Plastics News – Technical Notebook July 1998.
– Determination of Microstructure and Composition in Butadiene and Styrene-Butadiene Polymers by Near-Infrared Spectroscopy, C Miller, B Eichinger, T Gurley, J Hermiller, Analytical Chemistry, 1990, 62, 1778-1785.
– Determination of Terephthalic Acid at the Low Parts-per-Billion Level by Reverse Phase HPLC, T Gurley, Journal of Chromatographic Science, 1980, 18, 39-41.
– Analysis of Organophosphorus Compounds at the Parts-per-Million Level by Phosphorus-31 Fourier Transform NMR Spectroscopy, T Gurley and W Ritchey, Analytical Chemistry, 1976, 48, 8, 1137-1140.
– Phosphorus-31 Fourier Transform Nuclear Magnetic Resonance Spectrometry as a Trace Analysis Tool for the Determination of Inorganic Phosphates, T Gurley and W Ritchey, Analytical Chemistry, 1975, 47, 8, 1444-1446
– Ph.D. Thesis Phosphorus-31 Fourier Transform NMR Spectroscopy as a tool for trace analysis of Phosphorus Compounds. Thesis Advisor: William Ritchey, Case Western Reserve University, June 1976
Presentations
– Pharmaceutical Elastomer University
– Application and Limitations of TPEs for Use in Pharmaceutical Products, New Biomedical Developments in TPES, ACS Rubber Division meeting, Akron, Ohio, May 2006
– Shedding the Coating Myth: A Comparison Coated and Uncoated Drug Closures, PDA Extractables Conference, poster, May 2005
-Synthetic Polymers used in Pharmaceutical Applications, Wound Healing Consortium, Akron General Hospital, Akron, OH, March 2008
-Polymers that can save your Life, 2008 American Institute of Chemical Engineers Regional meeting, University of Akron, Akron, OH March 2008
Consulting Services
Extractables and leachables in:
· pharmaceutical rubber
· synthetic and natural rubber
· flexible PVC and other polymers
· plastic materials
Applications of analytical chemistry
· problem solving
· characterization
· methods development – chromatography / spectroscopy
· quantitative analyses
· process analytical chemistry methods
Training Services
– Training on pharmaceutical rubber formulations – chemistry, rheology, drug interactions, generic drug strategies (Pharmaceutical Elastomer University
– Training on USP, EP, JP requirements 87, 88, 381, 661
– Strategic business planning SWOT analyses