Industry Consultant - Richmond, VA 1993 – Present
- Serve as a Research & Development (R&D) Consultant for pharmaceutical and pet food corporations.
- Strategically manage GxP projects. Studies often were performed across multiple test sites.
- Identifying studies for regulatory submission.
- Preparing study protocols in collaboration with test facilities and sponsors.
- Function as an interface between contract laboratories, clients and project teams, providing progress updates, strategic planning and decisions, project schedules.
- Interface with contract laboratories and clients in preparation and approval of project/study contracts.
- Monitored animal health and human clinical studies.
- GCP investigator site audits
- Inspection readiness
- Vendor/supplier audits
- Quality Management System (QMS) audits
- Audit and remediate audit findings – clinical and GCLP bioanalytical studies
- TMF, Interactive Response Technology, and CLIA audits
- Prepared clinical study reports.
- Selection and qualification of contract laboratories to perform non-clinical, bioanalytical validations and bioanalytical studies.
- Qualification of vendor’s QMS
- Review of contracts and scope of work documents between sponsors and contract laboratories for accuracy and completeness.
- Perform GLP facility and study audits (method validations, bioanalytical, ADME, toxicity, and PK/TK) - preparation of audit agenda, perform the audit, prepare audit report, and remediation of audit findings in consultation with CRO and client.
- FDA readiness inspection
- Provide Quality Assurance activities for a university bioanalytical laboratory.
- Establish GLP compliance for bioanalytical/toxicity test facilities.
- Provide GLP training.
- Prepared set of GLP study monitoring SOPs.
- Study/project monitoring:
- Select/qualify CRO
- Generate study protocols
- Provide technical expertise
- Onsite monitoring
- Review data and study reports for compliance with the study protocol, applicable regulations and client/CRO standard operating procedures.
- Provide continual updates to the client.
- Accountable for the following types of preclinical studies:
- Analytical methods development/validation in multiple matrices, e.g., plasma, tissues, excreta, feeds, and crops.
- Bioanalytical studies in support of clinical and preclinical studies.
- Absorption, distribution, metabolism, and excretion (ADME) (in vivo and in vitro).
- Metabolite identification, protein binding, in vitro intestinal absorption models, enzyme assays, and in vitro drug interactions.
- Biocompatibility (ISO-10993).
- Toxicity (chronic, acute, safety, inhalation, and reproductive and developmental).
- Pharmacokinetics, toxicokinetics, bioequivalence, and bioavailability.
- Dose confirmation, efficacy, and target animal safety.
- Release analyses for clinical and preclinical studies.
- Environmental fate, ecotoxicity, aquatic toxicity, crop residue analysis, nature of residue, and metabolism.
- Conduct CMO Vendor Quality Management Systems, facility and study audits – prepare audit agenda, perform audits, remediation of audit findings, prepare audit reports, and client follow-up.
- Selection and qualification of contract laboratories to perform analytical studies in compliance to GMP regulations.
- Review of contracts and scope of work documents between clients and contract laboratories.
- QC/QA of CMC records, documents, reports.
- Laboratory instrument qualification – managed a team of contractors who qualified laboratory instruments as well as prepare and execute IQ/OQ/PQ protocols.
- Develop study protocols in collaboration with test facilities and clients, monitor studies, provide technical expertise, provide clients with study progress, review data and study reports for compliance with the study protocol, applicable regulations, and client/test facility standard operating procedures.
- Monitor and fully accountable for the following types of studies at test facilities:
- Analytical methods development, validation and analysis - stability-indicating methods, Active Pharmaceutical Ingredient (API) in raw materials, API and API-related impurities for product release and storage stability studies.
- Coordinate and oversee method transfer studies between contract laboratories.
- Characterization and re-certification of API and API-related impurities.
- Synthesis of API and API-related impurities reference standards.
- Storage stability of API and API-related impurities and final products.
- Provide input into establishing product specifications.
- Laboratory and manufacturing investigations with root cause analysis and CAPA resolution.
- Draft, implement, and review SOPs.
- Write and provide comprehensive regulatory documents such as clinical study reports, bioanalytical and analytical method validation, metabolism, toxicity, kinetic reports, API characterization, and storage stability reports, IND, executive summaries, literature reviews, and approximately 140 safety assessments of pharmaceuticals, excipients, plastic leachates, and compounds in cigarettes using published literature reports.
Subcontractor for various Consulting and Recruiting Firms:
- GMP, GCP, and GLP vendor and audits
- Investigator site audits
- Quality Management Systems audits
- Prepare SOPs
- Review and remediate findings – validation, bioanalytical, preclinical, CMC, and clinical studies.
- Inspection readiness
- Laboratory instruments qualification – prepare and execute IQ/OQ/PQ protocols.
- Manufacturing investigations with root cause analysis and CAPA resolution.
- Watson LIMS, Analyst Chromatography, Microsoft Office applications, SharePoint, ChemDraw, SigmaPlot and Visio.
TOXICOLOGY/REGULATORY SERVICES, Charlottesville, VA 1992 – 1993
Director of Chemistry & Environmental Sciences
- Served as a Consultant specializing in the oversight of EPA-regulated aquatic and mammalian toxicology, environmental fate, crop residue analysis, and nature of residue studies.
BIOCLIN, INC., Richmond, VA 1990 – 1992
Manager – Bioanalytical Laboratory
- Established GLP compliance for the bioanalytical laboratory.
- Managed a group of scientists performing bioanalytical methods development, validation, and analysis.
- Review and finalization of study reports.
A.H. ROBINS COMPANY, Richmond, VA 1980 – 1990
Manager – Drug Disposition
- Performed and directed bioanalytical method development and validations.
- Developed and validated radioisotope binding assays.
- Performed and directed ADME studies using unlabeled and radioisotope-labeled compounds.
- Reviewed data and prepared final study reports.
- Interaction with FDA scientists - presentation and discussion of study results.
- Direct supervision of scientists.
Education & Affiliations
Postdoctorate in Veterinary Pharmacology and Toxicology, University of California, Davis, CA
Ph.D. in Animal Science, Michigan State University, East Lansing, MI
M.S. in Animal Science & B.S. in Microbiology, Ohio State University, Columbus, OH
Affiliations: Society of Quality Assurance & American Chemical Society