Analytical, CMC and Specification Consultant for Pharmaceutical Drug Substance and Drug Product Development

Expertise

• Assessing specification and CMC analytical development for pharmaceutical drug substances and drug products.
• Analytical project planning and strategies for early, mid and late stage development programs.
• Writing, editing, and reviewing analytical technical reports.
• CMC and regulatory submission documents for Health Authority and FDA responses.
• HPLC method development, validation and transfer.
• Subject matter expert for the isolation and identification of synthetic impurities and degradation product unknowns.
• Contract Research Organization (CRO) management.
• Analytical Investigations.
• Due diligence preparations.
• Analytical life cycle product support; competitor analysis.
• Improving Analytical Partnerships - organizational development.

Experience

Independent Consultant-Present

Schering-Plough Research Institute, Summit, NJ, Senior Principal Scientist, 1989 - 2009

• Leadership of global analytical teams supporting drug substances and drug products in development (toxicological drug substance release through NDA post-submission support).
• Managed and developed groups of up to 9 scientists in both research and GMP environments. Managed CRO relationships.
• Proposed broad analytical strategies and executed specific tactical plans for drug substance and drug product analysis, excipients, equipment cleaning, dissolution testing, physical-chemical analysis, and microbiological analytical inputs.
• Key CMC author for regulatory submissions using the common technical document (CTD) format.
• Led a thrombin receptor antagonist analytical program from Phase I to Phase III.
• Served as Analytical Team Leader for the reformulation of temozolomide capsules.
• Led the analytical program for a priority CNS compound from pre-Tox to Phase I.
• Led global matrixed analytical teams, with partners in Puerto Rico, Ireland, Finland, Switzerland, Belgium, Singapore, and Japan.
• Developed and validated test methods following ICH Guidelines.
• Supported drug substance and product development. Quantified impurities, degradation products, and potentially genotoxic compounds.
• Assured critical quality attributes, and chemical, physical, and performance stability.
• Applied advanced expertise in HPLC method development, achieved difficult chiral and isomeric separations.
• Leveraged specialized stationary phases, alternate detection modes, and LC-MS to overcome scientific challenges and to isolate and identify chromatographic unknowns.
• Subject matter expert for the isolation and identification of synthetic impurity and degradation product unknowns.
• Responded rapidly to health authority and FDA regulatory questions.
• Proposed, justified, and implemented drug substance and drug product specifications.
• Analytical subject matter expert for FDA meetings, and SME for due diligence evaluations.
• Authored approved CMC content for: Elocon Cream, Claritin-D 12 Hour Tablets, Azium Powder, Azium Solution, Claritin Syrup, Clarinex-D 24 Hour Tablets and Temodar Capsules.
• Co-validated registration drug substance testing methods with the commercial manufacturing site saving time and technology transfer costs.
• Thorough knowledge of GMPs and quality systems for drug substance and drug product testing.
• Discovered and implemented three novel analytical techniques including a simple performance test of petrolatum to predict the potential for future ointment bleeding.
• Implemented efficiency initiatives including automated sample preparations, partnered QbD product development, UPLC applications and simplified testing of process ranging samples.
• Championed Consent Decree culture change by drafting and revising SOPs and participating in several important process re-engineering projects.
• Co-authored two training modules (isolation and identification of unknowns; and, specification development) for a CMC Fundamentals training course designed to develop junior staff in the pharmaceutical sciences.

Purdue Frederick Research Center, Yonkers, NY, Research Scientist, 1987 - 1989

• Developed and validated HPLC and dissolution methods supporting product development, and release and stability testing.
• Created a Reference Standard system and standardized formatting of test methods.

Warner-Lambert, Lititz, PA, Associate Analyst, 1984 - 1987

• Tested excipients, intermediate materials, pharmaceuticals, consumer health products, and stability samples in the QC laboratory. Backup LIMS System Manager.

Honors & Publications

Academic and Professional Affiliations

• American Association of Pharmaceutical Scientists
• North Jersey Chromatography Group
• Chromatography Forum of Delaware Valley - Life Member

Credentials

• Finalist for the Desty Award for Innovation in Separation Science

Publication

• 17 publications, posters, and presentations

Education

• M.S. Industrial Pharmacy, Long Island University, Brooklyn, NY
• B.S. Chemistry, Juniata College, Huntingdon, PA