1966 B.S., Chemistry, Brigham Young University, Provo, Utah
1969 M.S., Microbiology, Brigham Young University, Provo, Utah
1975 Ph.D., Medicinal Chemistry, University of Utah, Salt Lake City, Utah
PROFESSIONAL EXPERIENCE 1994 - present
Consultant to the pharmaceutical industry in the following
areas:
Assembly
and review of Chemistry, Manufacturing
and Controls documents for INDs,
NDAs & ANDAs
Assembly and review of DMFs
Analytical & API Audits/Preparation for Preapproval Inspections
Consent Decrees and CAPA Initiatives
In-house GMP training
ICH Initiatives including Stability Guidance, Impurities, Degradants & Organic
Volatile Impurities
All aspects of Quality Assurance/Quality Control including instituting
Quality
Systems and Quality Policies.
Analytical work/validations including establishing an Analytical/QC function
Validity Assessments and Data Integrity Audits
Due Diligence Audits
DEA systems including procedures and audits
1991 - 1994
Boehringer Mannheim Pharmaceuticals
(Formerly at)
101 Orchard Ridge Drive
Gaithersburg, MD 20878
Responsible for all aspects of Product Development and Quality Assurance
including interaction with international affiliates and contract manufacturers.
Built
out and staffed analytical laboratories including all aspects of Quality
Control. Established the QA function including SOPâs and all associated
systems. Staff of 14.
1989 - 1991
Janssen Research Foundation
Titusville, NJ 08560
Director, Product Development
Responsible for assembly and review of numerous INDs and NDAs. Functional areas
included analytical laboratories, bioanalytical laboratories and formulation
development. Staff of 20.
1985-1989
Janssen Pharmaceutica
Director, Quality Assurance/Technical Services
Responsible for all aspects of QA, analytical & bioanalytical Labs.
1982-1985
Ortho Pharmaceutical Corporation
Research Manager, Drug Characterization
Responsible for analytical methods development, characterization and specifications
for new drug substances.
1975-1982
American Critical Care
Group Leader, Analytical Development
1973-1975
University of Utah
Research Assistant, College of Pharmacy
PUBLICATIONS
Over twenty-five publications and numerous meeting presentations available upon
request.
PROFESSIONAL ORGANIZATIONS
American Association of Pharmaceutical Scientists
American Chemical Society
Drug Information Association
