Pharmaceutical Analysis Expert in Spectroscopy, Quality Control, and Research and Development

Expertise

• Internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near infrared and multivariate analysis.
• 19 years of pharmaceutical analysis in quality control, technical services and research and development.
• Technical Services Chemist with experience in troubleshooting High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) (Hewlett-Packard, Varian head space analyzer) methodology.
• Reviewed laboratory instrument qualifications and supporting data; helped to remediate documentation and procedures in the laboratory.
• United States Pharmacopeia (USP) Scientific Fellow and Liaison to the General Chapters, Pharmaceutical Waters and Statistics Expert Committees.
• USP in-house expert on the FDA Process Analytical Technology (PAT) and Quality by Design (QbD) initiative.
• Pharmaceutical drug substance and drug product chemical analysis in quality control, technical services and research and development
• Raw materials, finished products routine release, stability, and complaint samples testing.
• Controlled drug substances.
• Pharmaceutical cGMP Method development and validation in gas and high performance, ultra performance chromatography, ultra-violet/visible, FT-Infrared, near infrared, raman spectroscopy, dissolution, and Karl Fischer moisture analysis.
• Near infrared and chemometrics/multivariate analysis method development and validation.
• Pharmaceutical laboratory equipment installation qualification, operation qualification, and performance qualification (IQ/OQ/PQ)
• Method technical transfer.
• Comprehensive product assessment and trending report for the following categories:
• Recalls / Field Alerts
• Deviations / Exceptions / OOS Results
• Stability Data
• Change Controls
• Method Validation

Experience

Undisclosed Company, Owner, 2008 - Present

Projects

• Conducted reviews of client laboratory data in support of product submissions.
• Reviewed laboratory instrument qualifications and supporting data; helped to remediate documentation and procedures in the laboratory.
• Comprehensive product assessment and trending report for the following categories:
• Recalls / Field Alerts
• Deviations / Exceptions / OOS Results
• Stability Data
• Change Controls
• Method Validation

The Research Institute for Fragrance Materials, Inc. (RIFM), Woodcliff Lake, NJ

• Create FFIDSs (Flavor/Fragrance Ingredient Data Sheet) to assist RIFM member companies in the development of material safety data sheets (MSDS) for fragrance/flavor raw materials.
• Review all pertinent studies that RIFM has performed on file on a fragrance or flavor ingredient or a Natural Complex Substance (NCS).
• Enter a short summary of each report/published paper for that material into the RIFM/FEMA Database.
• Generate a formatted and edited version from the database.

Spherion, Bridgewater, NJ

• Perform analysis for the development of drug substance and products using process analytical technologies, quality by design and multivariate techniques.
• Solvent and moisture drying of API using NIR and PLS.
• Four step API Synthesis using Mid-IR.
• Thin film deposit on final product dosage patch using NIR.
• Involved in the modeling and implementation of real time drying, content uniformity, and monitoring drug synthesis for commercialized products as well as new drug substance under development.

Undisclosed Company, Director of Scientific Affairs, 2008 - Current

• Provides in-house scientific expertise with hands-on pharmaceutical industry experience.
• Delivers InfraTrac management and supports clients with advice, and leadership in the creation, coordination and delivery of Anti-Counterfeiting solutions, hospital verification system setup, analytical instruments, and consultation, Training and Support programs and services. InfraTrac scientific affairs strategy is structured to guide the development of InfraTrac programs and services through operations and project support as well as life-cycle management.
• Demonstrated industry leadership with expertise in developing, directing and coordinating innovative analytical solutions in pharmaceutical analysis.

United States Pharmacopeia, Rockville, MD, Scientific Fellow, 2003 - 2008

• Served as liaison for United States Pharmacopeia, General Chapters, Pharmaceutical Waters, and Statistics Expert Committees, plus additional international government agencies and the pharmaceutical industry.
• Worked to establish parameters for management consideration of process analytical technology to compendial policy.
• Recommended experts in spectroscopy and analytical chemistry to populate General Chapter and Reference Standards Expert Committees.
• Managed study as lead investigator on multi-laboratory project including U.S. FDA and private laboratory.
• Supervised study for the development of Near Infrared Spectral Libraries on multiple NIR spectrophotometers.
• Developed, drafted and directed study protocol; drafted instrument and model standards for developing, maintaining, and transferring chemometric methods between laboratories.
• Represented USP at PAT related symposia, conferences, and USP sponsored events.
• Led efforts to develop, revise, and publish the final USP General Chapter on near infrared spectroscopy
• Oversaw 30 new and revised general and informational chapters.
• Developed nine pharmaceutical water monographs, three general and informational chapters, and two new and revised general and information chapters.

Purdue Pharma L.P., Ardsley, NY, Principal Scientist, 1991 - 2003

• Supported the analytical method development for chromatographic, spectroscopic, potentiometric titrations, and dissolution analysis.
• Worked with U.S. FDA regulations.
• Utilized U.S. code of federal regulations parts 58, 210, and 211, in the creation, review, and implementation of pharmaceutical standard operating procedures.
• Produced required validation reports and analytical subsections for use in new drug applications, abbreviated drug applications, and chemistry manufacturing and controls procedures.
• Conducted pharmaceutical clinical studies, packaging verification, and product identification groundwork.
• Supervised the process analytics technology group for the development and implementation of the process analytical methods; performed 21 code of Federal Regulations-Part 11 validation audits.
• Introduced new NIR spectroscopy technique to research and development; applied feasibility testing to company products; purchased equipment, performed calibration, and installed qualification program.

Honors & Publications

Credentials

• Connecticut American Indian for Development Scholarship

Academic and Professional Affiliations

• USP Scientific Fellow with the United States Pharmacopeia (USP) and Liaison to the General Chapters, Pharmaceutical Waters and Statistics Expert Committees
• Council for Near Infrared Spectroscopy (CNIRS)
• International Conference of NIR Spectroscopy Pharmaceutical/PAT

Scientific Committee

• American Pharmaceutical Review Editorial Advisory Board
• Spherix Scientific Advisory Board
• Council for Near Infrared Spectroscopy - Governing Board, Member
• International Development Research Centre (IDRC), Chairman
• BUCHI Scientific Advisory Board
• ASTM Pharmaceutical Committee
• International Society for Pharmaceutical Engineering (USP Liaison), Member
• Product Quality Research Institute, Member
• American Society for Testing and Materials, Chairman, Chemometrics Committee
• Near-IR Validation Working Group (NIRVWoG), Chairman
• The Coblentz Society, Member
• Society for Applied Spectroscopy, Secretary, New York Chapter
• American Chemical Society

Awards

• Leo F. Rettger Microbiological Society Award

Publications and Patents

• Author of 25 papers and 46 presentations, (author of articles for; Journal of Near Infrared Spectroscopy, Journal of Pharmacopeial Forum and Pharmaceutical and Biomedical Analysis).
• 3 patents.