Analytical Chemist Expert in Validation of Methods for Pharmaceutical Regulatory Filings (1286)
Expertise
Separation science HPLC, ion chromatography, chiral HPLC, GC
Analytical method development and validation analytical method technical transfer
Laboratory equipment and instrument qualification and calibration
Design and setup of GMO and GLP Analytical Laboratories
Raw material and drug substance characterization
Physical chemical characterization and structure elucidation
Project management for bioanalytical and analytical laboratories
Bioanalytical method development
Quality assurance for GMO and GMOP laboratories
Preparation of the CMC section of an ND, NDA, eCTD
Regulatory specification development
Design and setup of cleaning validation program
GMP and GLP auditing of companies in SU, Europe and Japan
Experience
Independent Consultant, 2001-Present
Development and regulatory filing of new and generic pharmaceutical products. Provide expertise in the area of analytical chemistry, cGMP and quality auditing of the API and drug product manufacturing facilities, overseeing analytical method development and validation, preparation of SOPs, method validation protocols and instrument qualification protocols, technical transfer of analytical methodology, preparation and review of the CMC section of IND/NDA/ANDAs and other documents that are filed with the regulatory agencies.
Bioanalytical method development and validation.
Preparation and writing of the CMC section for eCTD, INDs, NDAs and ANDAs.
Preparation and writing of SOPs, instrument qualification protocols and calibration protocols.
For a new API supplier for Pre-clinical and Phase I/II materials, provided expertise for developing a cGMP facility and for establishing Process Chemistry, Quality Control, Quality Assurance, Information Technology and Document Control Departments.
Develop the company Quality Manual.
Atrix Laboratories, Inc., Director of Drug Delivery, 2000–2001
Research activities of ATRIGEL formulation development, liaison with external partners, review of the budgetary process, involved with new analytical technology, and provided guidance for analytical/bioanalytical method development and validation.
Provided guidance for all ATRIGEL formulations, both internal and external projects.
Liaison with external partners for drug development projects.
Provided support and guidance for analytical and bioanalytical method development and validation.
Geneva Pharmaceuticals, Principal Scientist/Head of Preformulation, 1997-2000
Preformulation activities as well as all analytical method development and validation for the active pharmaceutical ingredient and finished product. Final review and sign-off on all analytical reports, methods, validation protocols and specifications. Utilized by QC/QA for troubleshooting analytical methods. Communicated technical information with the FDA concerning pending and current products.
Provided analytical methodology and reports for more than 15 different products.
Successfully completed and transferred three preformulation projects to the project teams.
Communicated technical information to the FDA concerning three products that were under review resulting in final approval (sales of more than $50 million).
Wrote and implemented method development standards, method validation guidelines and protocols that resulted in faster and improved method development, more rugged methodology, and consistent, uniform method validation. Diverse drug substances including small molecules (organic and inorganic), potent drug substances, amino acids, and small to medium-chain peptides.
Hoechst Marion Roussel, Scientist, 1988-1997
Project development from pre-clinical to NDA filing for the active pharmaceutical ingredient and finished products. Managed analytical method development and validation including impurities, assay, content uniformity, cleaning validation, and identification for the active pharmaceutical ingredient and finished product. Prepared reports, analytical methods, and the Chemistry and Manufacturing Controls section of IND applications and amendments. Supervised five chemists.
Successfully filed 8 INDs and supplements.
Honors & Publications
Publications: numerous
Professional associations: American Chemical Society, American Association of Pharmaceutical Scientists, Parenteral Drug Association
Education
Ph. D., Analytical Chemistry, University of Iowa
B.S., Chemistry, cum laude, Oral Roberts University, Tulsa, Oklahoma