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Expert in Analytical Chemistry, Analytical Technology Development and Application
Available for your Consulting and Expert Witness Needs
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| Summary of Expertise: |
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Primary Expertise Areas:
(links show more experts in each area)
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Expertise Description: |
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drug development expert
analytical chemistry expert
drug clinical trial expert
drug formulation expert
drug regulation expert
drug validation expert
Food and Drug Administration validation expert
pharmaceutical chemistry expert
pharmaceutical design expert
pharmaceutical manufacturing expert
pharmaceutical product formulation expert
pharmaceutical research expert |
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. |
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pharmaceutical product development expert
pharmaceutical research and development expert |
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. |
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quality expert
quality assurance expert
quality assurance management system expert
quality auditing expert
quality control expert
quality evaluation expert
quality improvement expert
quality management expert
quality standard expert
pharmaceutical quality assurance expert
pharmaceutical quality control expert |
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). |
| Show Secondary and Basic Areas of Expertise |
Localities:
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.
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Degree |
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Subject |
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Institution |
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1986
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PhD
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Analytical Chemistry
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University of Georgia
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1977
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BS
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Chemistry/Psychology
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Barry University
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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2006 to
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(Undisclosed Consulting Company)
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Principal
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Consulting for Clients on NDA, Development and Compliance
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2003 to 2006
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Solvay Pharmaceuticals
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Manufacturing Quality Control
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Asst Director QC
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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.
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2000 to 2002
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Elan Pharmaceuticals
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Manager Analytical R&D
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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.
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1994 to 2000
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Procter & Gamble Pharmaceuticals
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Prescription Drug Development
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Sr. Scientist
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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.
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1985 to 1993
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Dow Chemical
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Analytical Sciences
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Project Leader
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Provided analytical support for product registrations and research. Developed and implemented production analytical procedures.
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Associations/Societies
AAPS
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Awards/Recognition
PA Traylor Creativity Award, The Dow Chemical Company; Special Recognition Award, The Dow Chemical Company
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Publications and Patents
He has several publications and patents.
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Conducted 3rd Party Audits as part of Consent Decree
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Established contracted R&D program for virtual company, including proposals, choice of contractors, monitoring of activities, report writing at each stage of completion
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Conducted market research for marketed products in regard to generic competion, technical hurdles and opportunities, Compiled summary reports
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As a member of the Intota consultant network,
Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as an Analytical Chemistry Consultant, Analytical Technology Development Consultant and Application Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company,
or consulting firm. Consultants service will be covered by a consulting contract.
Ask an expert initial screening questions and ask the experts services particulars, by simply submitting
an expert request.
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Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support,
forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright),
product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation,
and forensic testing if appropriate in litigation areas as an Analytical Chemistry Expert Witness, Analytical Technology Development Expert Witness and Application Expert Witness.
Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and
ask the experts services particulars by submitting an expert request.
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| International Experience: |
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| Years |
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Country / Region |
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Summary |
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2003 to 2006
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Germany/Netherlands
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Lead global teams for Waters Empower implimentation, Team members for analytical development Creon & Cilansitron
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| Language Skills: |
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| Foreign Language |
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Description |
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German
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Fluent
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Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Analytical Chemistry, Analytical Technology Development and Application.
Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for
custom business to business (b2b) and industrial market research. Intota uses analyst and
consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative
and quantitative data as well as report writing for the custom studies. The methods and tools
used by Intota market research combine the insights of technical experts and industry insiders with secondary
research to provide the custom b2b and industrial market research you need.
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Expertise
