- Pharmaceutical pricing.
- Pharmaceutical business development and sales.
- Pharmaceutical business strategy and decision making: Economic data analysis, tree analysis, probability of success calculations, resource and capacity requirements, drug pricing strategies, scenario presentations and critical path analysis.
- Pharmaceutical chemistry.
- Analytical method development and validation for drug stability, impurities, assay, release, content, uniformity, cleaning validation and identification.
Independent Consultant, 2003 - Present
- Business and pharmaceutical consulting.
Quintiles, Kansas City, MO, Director, Business Development 1999 - 2003
- Established pricing system for all Pharmaceutical Sciences products in the U.S.
- Implementation of sales plan with new sales growth of $36 million per year.
- Development of long term service agreements.
- Negotiation of proprietary technologies agreements.
- Process knowledge of multiple business lines and best practices for project and drug development.
- Expansion of business into areas and new clients.
- Worked with over 40 different companies selling pharmaceutical sciences, preclinical and Phase 1 services.
- Negotiated two new technologies for Quintiles.
Associate Director, Business Development, 1999 - 2001
- Development of pricing system for pharmaceutical sciences. This includes analytical chemistry services, pharmaceutical development and formulation services.
- Established and managed proposal group.
- Managed accounts and developed relationships with clients.
Global Project Manager, 1999
- Managed new drug development from discovery to post market.
- Similar duties, Project Manager and Research Chemist employed with Hoechst Marion Roussel.
Hoechst Marion Roussel Inc., Kansas City, MO, 1996 - 1999
- Managed new drug development.
- Implemented business case and project development plan.
- Coordinating activities with licensing and co-development partners.
- Optimizing the long-term and short-term tactical plans.
- Tracking and financial aspects of projects.
- Coordinating operational project team, including investigator drug brochure.
- Filing activities globally, including new drug applications, MAAs, INDs, CTAs.
- Presentation to senior management for viability of projects.
- Decision making using availabe of scientific and economic data: Decision tree analysis, probability of success calculations, target product profiles, plant capacity requirements and pharmaceutical.
- Responsible for project development and writing of methods for drug substance and drug product from pre-clinical to NDA filing, (GLP/GMP/cGMP).
- Chemistry section in IND applications, (including amendments) to regulatory agencies.
- Analytical method development and validation in: Drug substance, drug formulations, stability, impurities, assay, release, content uniformity, cleaning validation, identification.
- Setting specifications for drug substances and drug products according to USP/JP/EP/ EPA/FDA/ICH guidelines.
- Performing GLP and GMP audits.
- Responsible for answering questions from governmental agencies.
Bayer, Inc., Chemist, Stilwell, KS, 1989 - 1993
- Method development.
- Writing methods and Standard Operating Procedures (GLP).
- Study support and special projects.
- Instrument maintenance and troubleshooting.
University of Missouri, Visiting Instructor, Kansas City, MO, 1991 - 1992
- General analytical and instrumental chemistry laboratories.
Honors & Publications
Academic and Professional Affiliations
- American Association of Pharmaceutical Scientists
- American Chemical Society
- National Institute of Chemists
- MBA Finance, University of Missouri, Kansas City, MO
- M.S. Analytical Chemistry, University of Missouri, Kansas City, MO
- B.S. Biology, University of Missouri, Kansas City, MO