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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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Listed with other top experts in: |
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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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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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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).
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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 Summary
He has several publications and patents.
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| Selected Consulting Examples: |
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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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Recent Client Requests:
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Expert in packaging equipment design for consulting on feeding system for VFF's.
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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.
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Recent Litigation Client Requests:
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Expert in controlled release drugs for consulting on Doryx tablets for patent litigation.
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Expert in intota for consulting on The use of sugar alcohols as pharmaceutical excipients, specifically as possible stabilizers and moisture scavengers.
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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.
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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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Education
