Chromatography and Spectroscopy for Pharmaceutical, Medical Devices and Medical Packaging

Technical Consultant #1577


Expertise

  • Analytical chemistry problem solving - chromatography, spectroscopy, wet chemistry.
  • Analytical methods development - chromatography: HPLC, GC, GC/MS, LC/MS, GPC, SFC, SEC, and IC.
  • Ancillary analytical techniques: ICP, FTIR, TGA, NMR, AA, SEM, and XRF.
  • Analytical testing: Pharmaceuticals, polymer extractables and environmental contaminants.
  • Extractable and leachables from elastomer/polymer components of drug vial stoppers, IV set injection ports, IV bag ports, and baby bottle nipples.
  • Medical device elastomeric component product development and manufacturing.
  • Drug packaging: Parenteral drugs, vial closures, IV sets and bags.
  • Medical components manufacturing.
  • Process analytical chemistry using fiber optics, NIR, chemometrics and flow injection analysis.
  • Medical diagnostic blood testing focused on malaria.
  • International experience: Fulbright Scholar Ukraine, US Army German linguist in Berlin.
  • Training: Corporate Pharma Elastomer, Chemistry Instructor -University of Akron and Kent State University.

Experience

Undisclosed Company, President, 2006 - Present

  • Consulting in the area of analytical science related to polymers and pharmaceutical applications.
  • Taught Introductory Chemistry at several universities.
  • Conducted Pharma Elastomer University seminar for two pharmaceutical companies as part of a consulting contract.
  • Awarded Phase I SBIR grant by the U.S. Army to develop method to diagnose malaria.

Institute of Single Crystals, Kharkiv, Ukraine, Fulbright Senior Research Scholar, 2007

  • Conducted research on hydrogen bonding using microwave energy to acetylate several model iminocoumarines, molecules are known to have biological activity.
  • HPLC and NMR were used to analyze the reaction products.
  • Worked at the Institute of Single Crystals, Kharkiv, Ukraine, which is a post-Soviet government laboratory established in 1955.

Abbott Laboratories - Hospira Inc., Ashland, OH, 1992 - 2006

Technical Director, 2004 - 2006

  • Directed five groups - Rubber, Plastic, Latex, Process Engineering, and Tool Engineering.
  • 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 chemists and technicians including the analytical lab.
  • Responsible for development of new pharmaceutical /health care rubber products, primarily elastomeric closures, stoppers, reseals, baby bottle nipples, sponge, golf ball centers and hot water bottles.
  • 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 Research and Development.
  • 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.
  • Managed the development of a streamlined GC-TEA method for the determination of nitrosamines in baby bottle nipples.

Senior Analytical Chemist, (QA department) , 1992- 1993

  • Managed technicians and provided analytical support for production of rubber and plastic medical and consumer products.
  • Conducted audits in the research and development department.
  • Supported corporate QA audit of the manufacturing plant.
  • Developed new analytical testing instrumentation using fiber optics technology for QA release test for an acrylic clear multicuvette for clinical chemistry.

ICI Americas, Wilmington, DE, Group Leader, Separation Science, 1991-1992

  • Responsible for analytical support for several businesses within the Separation Science Division.
  • Managed 2 professionals and 6 technicians.

Goodyear Tire & Rubber Co. , Akron, OH, Section Head, Methods Development, 1982-1991

  • Managed a professional team of Ph.D.s 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.
  • Initiated company sponsorship of the Center for Process Analytical Chemistry (CPAC) at the University of Washington, Seattle.
  • Represented the company on the CPAC (Corrosion Prevention and Control) advisory board.
  • Developed programs and expertise in process analytical techniques - fiber optic remote spectroscopy, near infrared reflectance, chemometrics, FIA, process GC, and pulsed NMR.

Senior Research Chemist, 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.

Honors & Publications

Academic and Professional Affiliations

  • American Chemical Society

Credentials

  • Fulbright Senior Research Scholar
  • U.S. Army in Germany

Languages

  • German Linguist

Publications

  • Published one book
  • Authored many journal articles and given numerous presentations.

Education

  • Ph.D. Degree, Chemistry, Case Western Reserve University, Cleveland, OH
  • B.A. Degree, Chemistry, Houghton College, Houghton, NY
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