Pharmaceutical Consultant for Dissolution, Drug Delivery, Laboratory Quality and HPLC

Technical Consultant #1558

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.

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.

Publications