- GMP auditing of companies in U.S, Europe and Japan.
- Data integrity audits of quality assurance and quality control.
- Remediation of quality operation GMP inspection observations.
- FDA and foreign agency interactions by written response for applications and direct meetings for applications, inspections and other agency meetings.
- Successful FDA preapproval inspections of analytical lab.
- Successful FDA GMP and GLP inspections.
- Analytical method development, validation and method technical transfer.
- Separation science HPLC, ion chromatography, chiral, GC and CE.
- Spectroscopy methods for research and development and QC, UV-VIS, IR, NIR, Raman, NMR, MS.
- Thermal analysis, DSC, TGA, moisture adsorption.
- Metals analysis (ICP, AA) of pharmaceutical API and product.
- Laboratory equipment and instrument qualification and calibration.
- Design and setup of GMP and GLP Analytical Laboratories; quality assurance for GMP and GLP laboratories.
- Raw material and drug substance characterization.
- Preparation of the CMC section of IND, sNDA, NDA and common technical document (CTD).
- Evaluations of sources of counterfeit API and products; identified country of origin and supply chain.
- LIMS specification, selection and implementation for research and development and QC.
- Stability programs for registration and QC, API and product according to ICH and national guidelines.
- Polymorph and amorphous solids characterization and quantification using IR, DSC, powder x-ray diffraction and solid state NMR.
- Particle size determination using physical and optical methods.
- Development and validation of dissolution and disintegration methods for pharmaceutical products.
- Excipient-API compatibility studies.
- Compound and product licensing due diligence evaluation.
Independent Pharmaceutical Consultant, 2009 - Present
- Perform cGMP audits of pharmaceutical quality assurance and quality control, US, Europe and Japan.
- Perform data integrity audits of multiple quality control laboratories in US and Europe.
- Perform third-party quality assessment of released product and API for companies under FDA consent decree agreements.
- Remediation of quality assurance and quality control inspection observations under FDA 483, Warning Letter and Consent Decree.
- Assist companies with preapproval inspection readiness through evaluation of CMC submissions and mock FDA inspections.
- Provide companies with on-site support during FDA inspection.
- Evaluation of biosimilar equivalence testing towards meeting FDA guidance.
- Taught short course for using analytical techniques during trouble-shooting pharmaceutical development and manufacturing problems.
Cephalon, Inc., Salt Lake City, Utah, Senior Director, 2004 - 2008
Analytical Method Development, Drug Delivery Research and Development
- Led an analytical development and bioanalytical group in support of drug delivery research and support of commercial manufacturing and regulatory affairs.
- Directed analytical support for drug delivery group: small molecule, peptide and small protein bioanalytical in animal models, pharmaceutics and product analytical development.
- Prepared sections of, or reviewed supplemental, NDAs and authored responses to FDA questions for sNDA.
- Led preparation for FDA pre-approval inspection of analytical development which resulted in no 483 FDA observations.
- Participated on CMC review team for regulatory filings in Japan, Israel and Korea.
- Prevented product shortage through analytical support for method and formulation investigation in commercial manufacturing including meeting with FDA successfully argue that both a new method and specification were needed.
- Developed innovative new dissolution method to address method problems.
- Reviewed and approved change control for QC methods and manufacturing initiatives, participation in investigations and review of findings. Reviewed and modified corporate quality policies.
Pfizer Inc., Ann Arbor, MI, Senior Director, Pharmaceutical Sciences, 2000 - 2003
- Represented research and development addressing Information Technology (IT) issues during two mergers and leading team to develop laboratory information systems integration strategy.
- Led global research and development team which a developed multi-horizon laboratory information strategy.
- Developed user requirements and selected a LIMS vendor for Pharmaceutical Sciences in 6 months.
- Participated on global teams which developed the Pfizer-Pharmacia and Pfizer-Warner Lambert research and development IT merger integration requirements.
- Served as presenter and discussion leader for Pfizer Global research and development task force to establish and implement guidelines for API and dosage specifications during development.
- Developed drug and product specifications and impurity qualification as member of site committee.
- Directed analytical support for tracking source of illicit drug substance which enabled Pfizer to get unauthorized generic drug removed from market.
- Led analytical support of research which led to new patent protection for major drug.
Warner-Lambert, Ann Arbor, MI, 1986 - 2000
Senior Director: Analytical Development
- Managed a 35 member analytical, quality assurance, and information technology (IT) group for discovery, new drug development and commercial manufacturing support.
- Chaired worldwide group (3 countries, 6 sites) which developed policies and procedures for analytical method development during drug development.
- Built multidisciplinary group providing problem solving and forensics studies for research and development, manufacturing, QC, and international marketing that prevented product shortage and provided additional patent protection for multi-billion dollar products.
- Wrote guidelines for setting drug substance specifications.
- Established QC support for Clinical Pharmacy using near infrared spectroscopy.
- Developed with regulatory, product development and manufacturing groups specifications and NDAs for Lipitor and Rezulin and other products.
- Wrote research and development HPLC method validation policy.
- Authored major sections of CMC for NDAs of Lipitor, Rezulin, and Cerebyx and coordinated preparation of entire CMC.
- Analytical product support for peptide and peptoid based therapeutics.
- Reviewed and approved all departmental documents prepared for regulatory submission.
- Developed policies for certification and recertification of all standards used in research and development and commercial manufacturing, established and ran reference standard group.
- Reviewed all new corporate quality policies which impacted research and development and provided input.
Senior Research Associate and Director, Analytical Development
- Managed a group of eight, responsible for method development, stability studies, impurity identification and toxicological support analysis for drug substance.
- Prepared and coordinated preparation of CMC documents for IND and NDA submissions.
- Oversaw all API method revalidation under W-L consent decree.
Senior Development Chemist
- Analytical support for QC and API manufacturing.
Union Carbide, Senior Chemist, Analytical Development, RTP, NC, 1981 - 1986
- Analytical support for herbicide, insecticide and plant growth regulator, research and development and manufacturing.
Honors & Publications
Affiliations and Publications
- American Chemical Society
- Seven publications and presentations
- Ph.D. Chemistry, Biochemistry The Ohio State University, Columbus OH
- B.A. Chemistry, Berea College, Berea, KY