- Dissolution (reduction to a liquid form; liquefaction) method development, validation, transfer and troubleshooting.
- HPLC method development, validation and transfer.
- Laboratory instrument qualification and calibration.
- GMPs/ICH/USP: laboratory Quality Assurance and regulatory inspection readiness.
- Regulatory specification development.
- Preparation of the CMC (Chemistry, Manufacturing and Controls) section of IND (Investigational New Drug) and eCTD (Electronic Common Technical Document).
- Development of SOPs and Quality System.
- Evaluation of excipients and comparators.
Undisclosed Company, Principal Technical Consultant, 2008 - Present
- Provide consulting, problem-solving and technical training in the areas of dissolution, impurities, residual solvents, method development and validation, analytical instrument qualification or compliance (GMP/ICH/USP) and inspection readiness.
- Prepare SOPs for laboratory systems and documentation practices.
- Presents training course regarding development and troubleshoot dissolution methods, enabling participants to develop new methods and to systematically address and resolve issues.
- Presented training course on residual solvents and implementation of regulatory requirements for compliance.
Merck Research Laboratories, West Point, PA, 1981 - 2008
Director, Pharmaceutical Analytical Chemistry
- Technical direction and support for analytical method development, formulation selection, development of specifications and stability evaluation for new products.
- Built a GMP-compliance laboratory system with successful results in internal and external inspections.
- Developed a resource-sparing approach for data collection and review, instrument qualification, calibration and documentation, including notebooks, memos and regulatory CMC filings as part of a Six Sigma Black Belt team.
Director/Senior Manager/Section Leader, Pharmaceutical Analysis and Control, 1995 - 2005
- Provided support and guidance for dissolution method development, chemical and microbiological release and stability testing for pharmaceutical products under development (from Phase 1 through filing).
- Provide dissolution and stability support for excipients, comparators and radioactive formulations, related to ADME studies.
- Dramatically reduced resource requirements per project and cycle time for pharmaceutical research and development by focusing on true regulatory requirements.
- Co-led global Dissolution Task Force which developed and implemented SOPs that streamlined dissolution development, validation and specification setting.
- Co-led Interdivisional Specifications Team which developed and implemented a streamlined process for establishing specifications for new drug substances and drug products.
Senior Chemist, Pharmaceutical Analysis and Control, 1986 - 1995
- Developed analytical methods to support new product development, including over two dozen dissolution methods.
Kiwi Brands, Douglassville, PA, Manager, Quality Control, 1982 - 1986
- Oversaw quality for U.S. operations, including manufactured and purchased goods and raw materials, which included full responsibility for a staff of 6 chemists.
- Eliminate 95% of quarantine issues using a scientific approach to address issues.
Honors & Publications
Academic and Professional Affiliations
- USP Council of Experts - General Chapters, Vice Chair; Pharmaceutical Analysis Team and Biopharmaceutical Issues.
- PhRMA-Member of Dissolution Expert Committee, Representative to USP PT6.
- American Association of Pharmaceutical Scientists - Analytical and Pharmaceutical Quality Section and In-vitro Release and Dissolution Focus Group.
- Authored Over 17 text books chapters, articles and publications.
- M.S. Analytical Chemistry, Villanova University, Villanova, PA
- M.S. Chemistry, Drexel University, Philadelphia, PA