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 Expert  723519

Expert in Analytical Chemistry, Analytical Technology Development and Application

Available for your Consulting and Expert Witness Needs

Florida (FL)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support, validation and pre-clinical testing. His experience includes tablets, capsules, liquids, topical and biological (enzyme) products as applied to drug substances and drug product immediate & controlled release formulations. He has expertise in process and laboratory improvements both in quality and productivity, utilizing a variety of tools including time writing/trending analysis, automation and new technologies. He has proven technical and personal leadership skills and supervisory/training experience of BS/MS/PhD personnel.

drug development


analytical chemistry


drug clinical trial


drug formulation


drug regulation


drug validation


Food and Drug Administration validation


pharmaceutical chemistry


pharmaceutical design


pharmaceutical manufacturing


pharmaceutical product formulation


pharmaceutical research

Product Development · ANALYTICAL DEVELOPMENT & VALIDATION (R&D, QC): Design projects & programs. Develop/validate analytical procedures for new formulations (NDA). PAI readiness, including tech transfer to manufacturing, clinical stability programs, laboratory and system validations (CFR Part 11), Generate appropriate reports/documents. Immediate and controlled release, controlled substances (Schedule 1, 2, 3).USP Monograph packages. · PRODUCT, PROCESS & SYSTEMS: Update: analytical/process procedures, packaging, new process chemistry, analytical technique improvements, enhanced method documentation and procedures (GLP/ISO), Analysis/ID of impurities, FDA, EPA, Foreign registration.

pharmaceutical product development


pharmaceutical research and development

Laboratory Quality Systems · ANALYTICAL AUDITS: Conduct Global Laboratory Audits, assessing compliance and develop appropriate action plans for QC, R&D departments (US & Europe), outside suppliers & contract laboratories. Review internal audits; identify appropriate measurement tools and corrective actions (e.g. modify reports, OOS documentation practices). · DATA: Conduct data integrity evaluations, internal and contract lab, Review and approve electronic lab data and written reports. Review OOS/atypical data results/investigations. Conduct investigations, evaluate OOS/atypical data, and generate appropriate reports. · STAFFING: Hire & Train R&D and QC Staff, Conduct training in support of analyst certification (e.g. documentation practices, dissolution, HPLC theory, method validation).



quality assurance


quality assurance management system


quality auditing


quality control


quality evaluation


quality improvement


quality management


quality standard


pharmaceutical quality assurance


pharmaceutical quality control

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Miami, Florida;  Hialeah, Florida;  Fort Lauderdale, Florida;  Hollywood, Florida;  Pembroke Pines, Florida;  Port Saint Lucie, Florida;  Miami Beach, Florida;  West Palm Beach, Florida;  Pompano Beach, Florida;  and Boca Raton, Florida.

Year   Degree   Subject   Institution  
1986   PhD   Analytical Chemistry   University of Georgia  
1977   BS   Chemistry/Psychology   Barry University  

Work History:
Years   Employer   Department   Title   Responsibilities

2006 to


(Undisclosed Consulting Company)





Consulting for Clients on NDA, Development and Compliance

2003 to 2006


Solvay Pharmaceuticals


Manufacturing Quality Control


Asst Director QC


He most recently lead a 30+ staff QC organization. This was an integrated department which included micro, raw material, finished product and stability testing. The organization was also responsible for marketed product and limited NDA program support which included analytical method development, process support, validation and pre-clinical testing. The products range included tablets, capsules, liquids, topicals and biological (enzyme) products.

2000 to 2002


Elan Pharmaceuticals



Manager Analytical R&D


Led R&D laboratory staff developing controlled release formulations for controlled substances (Schedule 1,2,3). Reviewed and approved electronic lab data and written reports. Hired & Trained R&D and QC Staff. Managed entire R&D budget.

1994 to 2000


Procter & Gamble Pharmaceuticals


Prescription Drug Development


Sr. Scientist


Managed Global development projects/teams. Senior technical leader, responsible for validation, implementation, and automation of analytical procedures. Hired and trained lab staff. Responsible for R&D capital budget/expenditures.

1985 to 1993


Dow Chemical


Analytical Sciences


Project Leader


Provided analytical support for product registrations and research. Developed and implemented production analytical procedures.

Career Accomplishments:



PA Traylor Creativity Award, The Dow Chemical Company; Special Recognition Award, The Dow Chemical Company

Publications and Patents Summary

He has several publications and patents.

Consulting Services:
Selected Consulting Examples:
  • Conducted 3rd Party Audits as part of Consent Decree
  • Established contracted R&D program for virtual company, including proposals, choice of contractors, monitoring of activities, report writing at each stage of completion
  • Conducted market research for marketed products in regard to generic competion, technical hurdles and opportunities, Compiled summary reports
Recent Client Requests:
  • Expert in packaging equipment design for consulting on feeding system for VFF's.
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.

Expert Witness:
Recent Litigation Client Requests:
  • Expert in controlled release drugs for consulting on Doryx tablets for patent litigation.
  • Expert in intota for consulting on The use of sugar alcohols as pharmaceutical excipients, specifically as possible stabilizers and moisture scavengers.
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.

International Experience:
Years   Country / Region   Summary
2003 to 2006   Germany/Netherlands   Lead global teams for Waters Empower implimentation, Team members for analytical development Creon & Cilansitron

Language Skills:
Foreign Language   Description
German   Fluent


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