Expert Details
Analytical Chemistry, Analytical Technology Development and Application
ID: 723519
Florida, USA
Product Development
· ANALYTICAL DEVELOPMENT & VALIDATION (R&D, Expert): 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.
Laboratory Quality Systems
· ANALYTICAL AUDITS: Conduct Global Laboratory Audits, assessing compliance and develop appropriate action plans f, 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 Expert Staff, Conduct training in support of analyst certification (e.g. documentation practices, dissolution, HPLC theory, method validation).
Conducted 3rd Party Audits as part of Consent DecreeEstablished contracted R&D program for virtual company, including proposals, choice of contractors, monitoring of activities, report writing at each stage of completionConducted market research for marketed products in regard to generic competion, technical hurdles and opportunities, Compiled summary reports
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1986 | Degree: PhD | Subject: Analytical Chemistry | Institution: University of Georgia |
| Year: 1977 | Degree: BS | Subject: Chemistry/Psychology | Institution: Barry University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2006 to Present | Employer: Undisclosed | Title: Principal | Department: |
Responsibilities:Consulting for Clients on NDA, Development and Compliance |
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| Years | Employer | Title | Department |
| Years: 2003 to 2006 | Employer: Solvay Pharmaceuticals | Title: Asst Director QC | Department: Manufacturing Quality Control |
Responsibilities:He most recently lead a 30+ staff Expert 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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| Years | Employer | Title | Department |
| Years: 2000 to 2002 | Employer: Elan Pharmaceuticals | Title: Manager Analytical R&D | Department: |
Responsibilities: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 Expert Staff. Managed entire R&D budget. |
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| Years | Employer | Title | Department |
| Years: 1994 to 2000 | Employer: Procter & Gamble Pharmaceuticals | Title: Sr. Scientist | Department: Prescription Drug Development |
Responsibilities: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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| Years | Employer | Title | Department |
| Years: 1985 to 1993 | Employer: Dow Chemical | Title: Project Leader | Department: Analytical Sciences |
Responsibilities:Provided analytical support for product registrations and research. Developed and implemented production analytical procedures. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2003 to 2006 | Country / Region: Germany/Netherlands | Summary: Lead global teams for Waters Empower implimentation, Team members for analytical development Creon & Cilansitron |
Career Accomplishments
| Associations / Societies |
|---|
| AAPS |
| Awards / Recognition |
|---|
| 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. |
Language Skills
| Language | Proficiency |
|---|---|
| German | Fluent |
Fields of Expertise
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, pharmaceutical product development, pharmaceutical research and development, quality, quality assurance, quality assurance management system, quality auditing, quality control, quality evaluation, quality improvement, quality management, quality standard, pharmaceutical quality assurance, pharmaceutical quality control, pharmaceutical analytical chemistry, supervisory training, development technology, active pharmaceutical ingredient, investigational drug procedures, abbreviated new drug application, Good Clinical Practice, Good Manufacturing Practice training, pre-approval inspection, pharmaceutical technology, bulk drug, pharmaceutical liquid, generic drug manufacturing, drug product approval, over-the-counter drug product development, gelatin capsule, Food and Drug Administration compliance, Current Good Manufacturing Practice, pharmaceutical coating material, softgel capsule, analytical chemistry instrument, pharmaceutical manufacturing facility auditing, drug processing, tablet coating, pharmaceutical capsule, capsule packaging process, tablet manufacturing, over-the-counter drug regulation, drug safety testing, drug stability, tablet, pharmaceutical industry, pharmaceutical engineering, drug testing statute, new drug, Food and Drug Administration regulation, pharmaceutical drug, drug, tableting, quality engineering, over-the-counter drug, oral drug delivery, Food and Drug Administration new drug code, new drug application, investigational drug, Good Manufacturing Practice, Good Laboratory Practice, drug screening, bulk pharmaceutical chemical manufacturing