Analytical Chemistry Consultant: Drug Stability, API and Impurity Identification and Method Development

Expertise

• Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.
• Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.
• Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spectroscopic (MS, NMR, FT-IR, Raman) techniques.
• Polymer chemistry, organic solid state chemistry and surface chemistry as related to API and pharmaceutical formulations.
• Determination of impurity profiles and degradation pathways for new drug candidates.
• Evaluation of stability characteristics of early drug candidates.
• Expert in forced degradation studies and drug stability evaluation.
• In-depth knowledge of regulatory (FDA, ICH) guidance documents, GMP/GLP procedures, and quality by design concepts.
• Experienced technical writer and contributor to multiple NDAs, INDs and grants.

Experience

Undisclosed Company, NJ Founder and Principal, Present

• Founder of a consulting firm that supports the pharmaceutical industry and academia.

Hovione, LLC, East Windsor, NJ, Distinguished Scientist, 2006 - 2007

• Responsible for all analytical support to the synthetic process development chemists.
• Performed HPLC and GC method development and testing to support intermediate and final drug substance characterization, stability testing, and synthetic process edge-of-failure testing.
• Conducted spectroscopic characterization of intermediates and final drug substances in co-ordination with external spectroscopy labs.
• Effective interface with customers for project planning, administration and documentation.
• Provided method development guidance and laboratory assistance to the Quality Control group for drug substance assay and related substances release testing methods, residual solvents, Karl Fischer and cleaning verification testing.

Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, NJ, 1993 - 2009

Research Fellow, 2007 - 2009

• Provided direct laboratory support and managerial guidance to a multi-scientist group responsible for the analytical characterization of late phase drug substance and drug product formulations.
• Developed a variety of methods (assay, content uniformity, dissolution, Karl Fisher ID tests, ppm level methods for genotoxic impurities) for drug substance and drug product formulations in support of phase III and NDA filings.
• Designed and executed statistical robustness studies to support final methods.
• Introduced quality by design concepts into late phase method development.
• Utilized knowledge of mechanistic organic chemistry to identify and eliminate stability problems in drug product formulations.
• Identified impurities and degradation products in drug substances and formulations.
• Designed and executed stability investigations and excipient compatibility studies in support of formulation development and packaging decisions.
• Designed and executed quantitative color fading studies to support decisions on colorants for final marketed dosage forms.
• Contributed as technical writer on three NDA filings.

Director, Group Leader, Principal Scientist, Senior Scientist, 1993 - 2006

• Served in positions of increasing leadership responsibility culminating in the role of Director of a 21 scientist analytical Research and Development department comprised of the Method Development and Chemical Characterization Group, the Spectroscopy Group, the Chemical Development Support Group and the Preparative Separations Group.
• Guided or participated in the successful development of over 30 early phase drug candidates, including both drug substance and probe formulation support.
• Designed and implemented a program for evaluating stability characteristics of early drug candidates.
• Assisted in design and implementation of an automated forced drug degradation system.
• Managed all outsourced analytical project support activities.
• Harmonized early development activities across global sites.
• Managed staff development, budget planning, project management, writing of SOPs, and oversight of GMP and GLP compliance.
• Provided direct laboratory support for multiple early and late phase development projects (HPLC method development, stability studies, determination of degradation mechanisms, interpretation of spectroscopic data).
• Determined impurity profiles and degradation pathways for new drug candidates using analytical (HPLC, GC, CE, TLC) and spectroscopic (NMR, MS, FT-IR, Raman) techniques, and through the isolation of impurities using preparative HPLC.
• Served as technical writer leading or contributing to the writing of multiple IND filings and developmental reports included in NDA filings.

Albright College, Reading, PA, Assistant Professor, 1988 - 1993

• Responsible for both the Organic Chemistry and Advanced Organic Chemistry courses and associated labs.
• Obtained external funding for undergraduate research and led an undergraduate research program.

Honors & Publications

Academic and Professional Affiliations

• American Chemical Society
• American Association of Pharmaceutical Scientists (AAPS)

Awards

• Received the J&J PRD Standard of Leadership Award for scientific efforts in support of a complex cephalosporin antibiotic development project.
• Received Outstanding Achievement Award for support of the Levaquin Project.
• Received the Albright College Jacob Award for excellence in teaching.

Publications

• 8 publications.
• 5 presentations.

Education

• Ph.D. Organic Chemistry, Yale University, New Haven, CT
• M.S. Organic Chemistry, Yale University, New Haven, CT
• B.S. Chemistry, Duke University, Durham, NC