Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Analytical Chemistry, Analytical Technology Development and Application

ID: 723519 Florida, USA

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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.

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
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.
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.
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.
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.

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

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