Pharmaceutical CMC and New Drug Development Expert: Small Molecules, Proteins and Biologics

Technical Consultant #2052


Expertise

  • Accomplished chemist and regulatory professional with over 25 years' experience in Pharmaceutical and Biotechnology industries.
  • CMC (Chemistry, Manufacturing and Controls), analytical chemistry and drug development of small molecules, proteins and biologics (cells, viruses, plasmids).
  • CMC programs for oral, inhaled, topical and parenteral dosage forms.
  • Technical and program-level supervision of formulation, analytical and manufacturing in support of product-manufacturing processes for small molecule, protein, and plasmid therapeutics.
  • Strategic, technical, and regulatory direction for pharmaceutical development.
  • INDs/NDAs for the U.S. FDA, developing regulatory strategy, and liaison with FDA.
  • Regulatory and development.

Experience

Undisclosed Company, Founder and CEO, 2009 - Present

  • Consulting, pharmaceutical development for small molecules and biologics.
  • Advancing IND, (Investigational New Drug), projects from preclinical to POC, (Proof of Concept).
  • Development of formulations, dosage form, analytical methods, stability programs.
  • Outsource management of CMC, (Chemistry Manufacturing and Controls) and bioanalytical from audit to clinical studies.
  • Frequent interaction with CBER, (Center for Drug Evaluation and Research,) and CDER, (Center for Drug Evaluation and Research) of U.S., FDA.
  • Writing and review of regulatory documents to support INDs and NDAs.
  • Initiated operations: CMC consulting.
  • Planning and executing CMC regulatory submissions.
  • Managed intellectual property portfolio and patent prosecution.
  • Consulted and authored STTR (Small Business Technology Transfer), SBIR, (Small Business Innovation Research) and ATP, (Advanced Technology Programs) proposals.

Summit Drug Development Services, LLC, Rockville, MD, 2007 - 2009

Vice President, Pharmaceutical Development Services, 2008 - 2009
Consultant, CMC and Analytical Chemistry, 2007 - 2008

  • Managed development projects for multiple clients.

Scynexis, Inc., Research Triangle Park, NC, 2002 - 2007

Director of Scientific Affairs and Drug Development

  • Advanced HCV program from preclinical and pre - IND to Ph. 2 in 18 months.
  • Responsible for HIV and HCV discovery and development.
  • Responsible for preclinical research and regulatory operations.
  • Team leader for proprietary discovery program: antiviral and ophthalmology.
  • Inventor of several new therapeutics: antiviral and dry eye compounds.

Director of Analytical Sciences

  • Responsibility for QC analytical chemistry and bioanalytical functions.
  • Team of 14 scientists: GLP and cGMP compliant operations.
  • Project Team leader for drug-discovery project: antiviral agent.

Phytera, Inc., Worcester, MS, Director, Chemistry, 2000 - 2001

  • Medicinal chemistry and analytical chemistry in drug development programs.
  • CMC Regulatory writing.

Paradigm Genetics, Inc. , Research Triangle Park, NC, 1998 - 2000

Group Leader, Biochemistry

  • Small-molecule biomarker development.
  • Established initial metabolite screening, analytical methods/systems, and automation platform.
  • Biochemical-assay development team.

OSI Pharmaceuticals, Inc., Durham, NC, Uniondale, NY, Director of Chemistry, 1994 - 1998

  • Research-operations director for drug discovery center (screening and chemistry).
  • Responsible for research activities in biology and chemistry.
  • Member of Technology Development Committees.
  • Team leader in drug discovery projects (cancer, virology, hematopoiesis): Discovered antiviral agents, EPO inducers, and anti-sickle-cell agents.
  • Directed SAR programs.

Sterling Winthrop Pharmaceuticals, Research Division, Collegeville, PA, 1989 - 1994

Principal Research Investigator, 1993 - 1997
Senior Research Investigator, 1991 - 1993
Research Investigator, 1989 - 1991

  • For the Department of Biochemistry and Biomolecular Screening, managed biochemistry and biocatalysis research team.
  • Developed high-throughput assays for inflammation programs.
  • Developed functional and binding assays for new targets.
  • Developed novel HTS assay for metalloproteases.
  • Managed enzymology and biochemistry group.

Los Alamos National Laboratory, Los Alamos, NM, 1987 - 1989

Fellow, Isotope and Structural Chemistry Group

  • Enzyme kinetics and mechanisms of alcohol dehydrogenases.
  • Biocatalysis using PPQ-based dehydrogenase.
  • Synthesis and biosynthesis of isotopically labeled coenzymes and enzymes.

Merck and Company, Inc., Rahway, NJ, 1981 - 1987

Senior Biochemist, 1986 - 1987
Research Biochemist, 1984 - 1986
Biochemist, 1981 - 1984

  • Development research on biocatalytic processes, and production of anti-bacterials,statins, CCK receptor antagonists.
  • Developed analytical methods for over 100 compounds.

Honors & Publications

Academic and Professional Affiliations

  • Editorial Board, Journal of Antibiotics
  • North Carolina Regulatory Affairs Forum
  • Center for Entrepreneurial Development, NC
  • American Association of Pharmaceutical Scientists (AAPS)
  • Drug Information Association (DIA)

Awards

  • Recipient of Merck Ph.D. Fellowship and Research-Achievement Award

Publications and Patents

  • Author and Co-Author of Numerous: Meeting abstracts, scholarly journals, book chapters and symposia with the following topics:
  • National and international patents.

Education

  • Ph.D. Chemistry, Ohio State University, Columbus, OH
  • M.S. Biochemistry, Purdue University, West Lafayette, IN
  • B.S. Biology, Summa Cum Laude, Alma College, Alma, MI
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