Near Infrared & Instrumental Analyses

Expertise

• Development and design of Near-Infrared (NIR) instrumentation for process control applications and (NIR) feasibility application studies.
• Implementation and guidance of current FDA, USP for Instrument and Pharmaceutical companies for specific client needs.
• Biomedical instrumentation design and software for commercialization.
• Methods development for quality assurance - techniques utilized; HPLC, UVNis, NIR, FT-IR, HPLC, UVNis, NIR, FT-IR, GLC, laser particle sizer thermal analysis (DSCITGA), MS, plasma emission, surface area, physical parameters. (QA)
• Project management for the pharmaceutical industry.
• Instructor and trainer for: NIR and PAT courses in U.S., and Europe, N/R theory, applications, validation and documentation.
• IND, NDA Documentation preparation spectroscopy.
• Other areas: UV/Vis, FT-IR, atomic absorption, plasma emission spectroscopy, ion selective electrode, polarography, chromatography, GLC, HPLC, thermal analysis (DSC/TGA), surface area analysis, thermodynamics, and food testing.

Experience

Independent Consultant, 2009 - Present

Industrial

Doramaxx Consulting, Goldens Bridge, NY, President, 2009

• Teach short courses in near-infrared and PAT/QbD, (Quality by Design) in U.S. and Europe.
• Train analysts in NIR method development: Assist companies beginning PAT groups: assist in choosing correct instrumentation for PAT projects; design equipment for pharmaceutical analyses.

Cadrai Technology Group, Bel Air, MD, Chief Technology Officer, 2005 - 2008

• Responsible for technical portion of consulting contracts: evaluated new equipment suggested and installed new lab and process equipment.
• Taught NIR and PAT courses in U.S. and Europe. Trained in N/R theory, applications and validation documentation. Assisted instrument companies - designed and implemented new hardware and software; implemented new PAT/QbD programs.
• Designed and presented courses and webinars.

Integrated Technical Solutions, Greenwich, CT, Pharmaceutical Business Manager, 2001 - 2005

• Responsible for project management for pharmaceutical industry especially relating to near-infrared analyses and process analyses. Was part of PAT sub-committee to FDA advisory board and currently work with FDA, USP, instrument companies and pharmaceutical companies to implement current FDA guidance to specific client needs. In charge of training personnel and implementing hardware and software into regulated environments.
• Train in NIR applications, validations.

Purdue Pharma, LP, Ardsley, NY, Research Fellow, 1998 - 2001

• Group Leader for New Technology Group. Developed and implemented new (non-traditional) instrumentation for process control, physical methods, finished products.
• Developed biomedical instrumentation and software for commercialization.
• Methods included: Near-infrared, UV/Vis, raman, fluorescence, electrochemistry.
• Supervised group of degreed personnel. Generated 6 patent applications; 4 granted.

Merck & Co., Inc., West Point, PA, Developmental Chemist, 1992 - 1993

• Worked in development and design of Near-Infrared (NIR) instrumentation for process control applications; instructor in NIR theory and applications at U.S. and PR sites; consultant for NIR projects, improved HPLC methods used for NIR in method calibrations, and wrote methods and protocols for NIR work.

NIRSystems, Inc., Silver Spring, MD, Applications Scientist and Technical Consultant, 1982 - 1992

• Designed and performed NIR feasibility studies for customer applications; taught basic and advanced NIR courses; responsible for pharmaceutical and physical chemical applications of NIRS; presented experimental results at scientific meetings and conferences.
• Demonstrated NIR applications for customers; carried out experiments to support physical and chemical uses of NIR published in applications brochures; presentations given at scientific meetings and customer sites.

Bran & Leubbe, Inc., Elmsford, NY, Technical Consultant, 1987 - 1989

• Developed NIR analyses for physical/analytical applications; consulted in both hardware and software development projects; conducted training sessions for both employees and customers; wrote numerous applications notes.

Applied Analytical Industries, Inc., Wilmington, NC, Laboratory Director, 1988

• Trained and supervised personnel In HPLC theory and practice; re-structured operating and reporting system for the laboratory data.

Sandoz Pharmaceuticals, Inc., East Hanover, NJ, Developmental Scientist III, 1985 - 1987

• Methods Development for quality assurance; techniques utilized include HPLC, UVNis, NIR, FT-IR, GLC, laser particle sizer thermal analysis (DSCITGA), MS, plasma emission, surface area, physical parameters. (QA)

Supervisor

• Instrument Group in quality assurance; purchased, installed, calibrated, and maintained analytical/physical measurement instrumentation; taught HPLC theory and troubleshooting; supported raw material and in-process areas; introduced NIR as qualitative tool in pharmaceutical analyses.
• Supervised several degreed personnel. (QA)

Analytical Research Scientist

• Developed methods for analyzing and characterizing raw materials, intermediates, and finished pharmaceuticals in support of new products using GC, HPLC, plasma emission spectroscopy, thermal analyzer, UVMs , research and development.

Henkel Corporation, Hoboken, NJ, Laboratory Manager, 1977 - 1980

• Developed methods for analysis of surfactants for analytical research and quality control; provided technical support for both in-process and finished products; supervised eight degreed and non-degreed scientists.

Cooper Laboratories (Berlex), Cedar Knolls, NJ, Senior Analytical Chemist, 1973 - 1977

• Designed and ran stability program, developed stability indicating assays; wrote analytical sections of IND and NDA documents; methods utilized included HPLC & TLC, DSCITGA, ion-selective electrodes, polarography, GC; supervised five degreed scientists.

CIBA Geigy Pharmaceuticals, Summit. NJ, Associate Scientist, 1970 - 1973

• Performed analyses to support pre-formulation, formulation. and stability studies; developed methods for testing package/product compatibility for pharmacy research division.

Riegel Paper, Inc., Milford, NJ, Junior Chemist, 1970

• Developed thermal analysis methods to measure rate and degree of cure of thermosetting resins impregnated in filter paper using DSCIDTA.

Military

• Veteran, U.S. Army Infantry, 1967-1969

Honors & Publications

Educator

• PTi-International Short Courses, Instructor: Process Analytical Technology/Quality by Design.
• Center for Professional Advancement, Director- Short Courses, "NIR Spectroscopy In Pharmaceutical, "Practical Problem Solving Chemical Analysis" and "Implementing PAT."
• American Chemical Society, Lead Instructor,"Practical Near-Infrared Analysis" annually at PittCon, ACS National Meetings.
• Mount St. Mary's College, Emmitsburg, MO, Adjunct Facility, Taught Quantitative Analysis lecture and lab, instrumental analysis laboratory and mentored student research.
• Hood College, Frederick. MD: Adjunct Faculty, Taught Quantitative Analysis lecture and lab.
• Eleanor Roosevelt High School. Greenbelt, MO, Taught Physics, Chemistry, Chemistry Instrumentation, Environment Science and mentored student research.
• Seton Hall University, South Orange, NJ, Adjunct Faculty, Teaching Assistant, Taught Chemistry for Non-Majors, developed labs Organic Lab.
• College of St. Elizabeth, Convent Station, NJ, Adjunct Faculty, Analytical, General Chemical Lab, Instrumental Analysis, Physical Chemistry, Thermo and Lab, General Physics, General Lab and supervised student research.
• Caldwell College, Caldwell, NJ, Adjunct Professor, Taught Physics laboratory.
• New Jersey Institute of Technology, Newark, NJ, Adjunct Professor, Taught Instrument Troubleshooting and Instrumental Analysis.
• Stevens Institute of Technology, Hoboken, NJ, Adjunct Professor, Taught Quantitative Analysis, Instrumental Analysis and Instrument Troubleshooting.

Editorial

• Pharmaceutical Manufacturing, Editorial Advisory Board. Contributing Editor for monthly column: 'Therapeutic Dose" OP-Ed articles pertaining to PAT (Process Analytical Technologies), QbD (Quality by Design) initiatives of the FDA. Editorial Advisory Board: Articles written for audio and video formats.
• Journal of Process Analytical Technologies, Editorial Advisory Board
• Journal of Process Analytical Chemistry, Pharmaceutical (Contributing) Editor
• American Pharmaceutical Review, Editorial Advisory Board
• Pharmaceutical Technology Contributing Editor for "PharmAnalysls" column series on new analytical trends and validation topics for the Pharmaceutical industry
• Food Testing and Analysis, Editorial Advisory Board
• Spectroscopy Magazine, Contributing Editor for "Molecular Spectroscopy Workbench" column series of articles on spectroscopic technique and theory

Academic and Professional Affiliations

• American Chemical Society
• Society for Applied Spectroscopy
• Council for Near-Infrared Spectroscopy (NIRS)
• International Diffuse Reflectance Conference
• PAT Validation Working Group (FDA/PAT initiative)
• USP Expert-Sub Committee

Awards

• The American Society for Business Press Editors' (ASBPE) Award
• Eastern Analytical Symposium Award: "Contributions to NIR"
• New York Society for Applied Spectroscopy Award for Graduate Research
• Society of Cosmetic Chemists, "Most Meritorious Paper"

Publications and Patents

• Six texts, three in preparation, six chapters (invited), over 40 published papers, 150 presentations, (presented papers or posters).
• 7 patents with an additional 5 pending.

Education

• Ph.D. Analytical Chemistry Research, Seton Hall University, South Orange NJ.
• M.S. Chemistry, Seton Hall University, South Orange NJ
• M.S. Chemistry Rutgers University, Newark, NJ
• B.A. Chemistry Rutgers University, Newark, NJ