CMC Consultant Specializing in the Development of Small Molecule Therapeutics

Technical Consultant #1911


Expertise

  • Physical and analytical chemistry for CMC support of small molecule drug development.
  • Chemical and formulation process development for API and various dosage forms.
  • Material characterization of API and dosage forms for process development and troubleshooting.
  • Analytical development, method validation and transfer for development and commercial methods; data analysis and interpretation of trends.
  • Coordination of CMC activities with toxicology, clinical, QA/QC and regulatory affairs line functions
  • Project and supply chain management to meet all development milestones.
  • Development and review of CMC source and submission documents, and responses to regulatory findings.
  • Familiar with quality systems development and utilization in both research and development and the commercial environment.

Experience

Undisclosed Company, President, 2007 - Present

  • Provide expert input into protocol development and execution of validation studies for analytical API process control methods at a client's CMO in Europe.
  • Evaluate physical properties to identify proper API source to resolve dissolution behavior issue with a solid dosage form.
  • Coordinated client development efforts on a new diabetes drug with their CRO, CMO and academic partners, and contributed to IND CMC preparation and review.
  • Advised client to re-define their molecular entity (develop alternative API salt), which successfully overcame a maximum infusion volume issue for their IV dosage form.
  • Managed complex (international and multi-site) services and supply chain, plus analytical method development and validation for a novel gel product.
  • Recommend and oversee the development of a dispersed form of a poorly soluble API that resulted in providing a 300X improvement in bioavailability for the solid dosage form.
  • Correctly interpreted poor dissolution recovery of an active from an immediate release dosage form as an interference (diffusion-controlled; high viscosity regime) due to the major excipient.

Cardinal Health, Morrisville, NC, Director, 2003 - 2006

  • Managed a group of scientists responsible for analytical research and development services for sponsors within the pharmaceutical industry.
  • Services include analytical methods development, validation and transfers, and release and stability testing for small molecule APIs and drug products.
  • Led the effort to develop a formalized career path matrix for technical and management personnel for implementation.
  • Interfaced with customers one-on-one or via teleconference to present company services and capabilities, address drug development tactics and strategies to meet their needs, and provide updates on technical project progress.
  • Coordinated comprehensive technical and documentation support for the development of Cardinal's first entry into the generic drug markets, this product participation strategy provided potential annual revenue of $500 million.

Pfizer, Skokie, IL, Senior Director, 2003

Pharmacia, Skokie, IL, Senior Director, 2000 - 2003

Monsanto Corporation, Skokie, IL, Director, 1995 - 2000

  • Managed the Global Chemical Process research and development and analytical research and development groups located in St. Louis, Skokie and Kalamazoo.
  • These groups, comprised of over 100 analytical scientists, were responsible for analytical research and development activities supporting small molecule chemical process research and development throughout product lifecycle.
  • Provided analytical in-process support for small molecule API process research and development, and marketed product support.
  • Provided timely and effective analytical support to groups outside the chemical sciences process development group, including discovery research and pharmaceutical development.

Section Head and Group Leader, 1992 - 1995

  • Managed the Chemical Sciences Analytical (CSA) group, including the development analytical, physical methodology, discovery analytical and compliance groups.
  • Provided analytical in-process support for small molecule API process research and development, and marketed product support.
  • Provided timely and effective analytical support to groups outside the chemical sciences process development group, including discovery research and pharmaceutical development.
  • Effectively integrated the Skokie and St. Louis analytical research and development groups in terms of work practices and procedures.

Research Scientist II, Research Scientist I and Research Investigator, 1985 - 1992

  • Supervised the Development Analytical group responsible for analytical support for 4-shift API pilot plant operations, chemical process research and development for new chemical entities, reference standard certifications and raw materials testing in the Chemical Sciences group.
  • Based on the 1987 FDA guidance for implementation of GMP concepts to bulk pharmaceutical chemicals, developed efficient and compliant work processes and procedures for laboratory controls and documentation practices for use in a research and development environment.
  • Developed and validated HPLC methods for numerous active pharmaceutical ingredients (APIs). Utilized FTIR and thermal analysis methods to characterize polymorphism in several products.
  • Utilized a reversed-phase HPLC method incorporating pulsed amperometric detection for the analysis of a synthetic amino-sugar drug substance.
  • Participated in a 16-month rotation program through several laboratories in the product development area before assuming a permanent assignment in the Product Development Analytical Department.

Honors & Publications

  • Instructor for Frontline Leadership Program (Pharmacia)
  • Legal Training for Managers (Winston & Strawn)
  • PERI Course on Drug Development (PERI)
  • GMPs for Executive Management
  • IRI Kellogg Technology Managers Program (Northwestern University)
  • CFR 21 Part 11 Training (R. Mason)
  • Theory of Constraints Training (K. Fox, TOC Center)
  • Barr Decision Training (Torbeck Associates)
  • Covey Seven Habits Training
  • Variation and Managerial Action (Joiner Associates)
  • Fourth Generation Management (Joiner Associates)

Academic and Professional Affiliations

  • Member of American Chemical Society
  • Member of American Association of Pharmaceutical Scientists

Publications and Patents

  • Author and Co-Author of publications in medical journals and for meetings and conferences.

Education

  • Ph.D. Physical Chemistry, Michigan State University, East Lansing, MI
  • M.S. Physical Chemistry, Bowling Green State University, Bowling Green, OH
  • B.S. Chemistry, Bowling Green State University, Bowling Green, OH
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