CAREER SUMMARY
· Pharmaceutical Development Scientist, Consultant and Expert Witness having more than 30 years’ experience developing pharmaceuticals.
· Expert Witness for Law Firms and Companies in US Paragraph IV Hatch-Waxman and Canadian Notice of Allegation innovator vs. generic pharmaceutical dosage form patent litigation, in-licensing due diligence, and contract dispute involving commissions and patented technologies. Supported Claims Construction, Consulted as an Expert, Wrote Expert Reports and Testified at deposition and trial.
· Consultant to Multinational Big, Medium and Virtual Pharma Companies, Academia and NIH. Projects included Project/Product Development Management; Preformulation Support; Author and Reviewer of Chemical Development, Pharmaceutical Development, and Process Validation Reports, CMC Sections of INDs and NDAs.
· Pharmaceutical Development Scientist/Manager for 20 years at McNeil Pharmaceutical and the R.W. Johnson Pharmaceutical Research Institute, (Johnson & Johnson Family of Companies) providing Preformulation Physical-Pharmacy support for Formulation Development, pre-Clinical and Clinical Development, Medicinal and Developmental Chemistry, Biological Sciences Departments and Manufacturing; characterizing NCEs resolving problematic NCE and dosage form properties, anticipating needs, advancing projects, regulatory filings and departmental capabilities; interacting with intramural departments and extramural vendors; keeping projects and filings on schedule.
· Pilot Plant Operations Manager for 4 years at Therics Inc, Novel Drug Delivery/Dosage Form and Tissue Engineering (Bone) Development Company. Responsibilities included providing cGMP training, a dual operational facility for non-cGMP R&D activities and a fully functional cGLP and cGMP compliant facility for manufacture of pre-Clinical,, Clinical, Demonstration and Regulatory Stability Batches.
· Core specialties include CMC Development issues, Preformulation, Physical-Pharmacy, Analytics, cGMP Operations, Project Planning and Management.
· Overall Experience has resulted in highly developed management and writing skills; extremely wide range of direct and indirect product development experiences in multi-national large, medium, small and virtual Pharma companies.
· Author of 17 published Manuscripts, 12 Meeting Abstracts, 25 Invited Symposium topics, Seminars and Courses, and 5 Articles in Pharmaceutical Magazines.