I am a provider of contract/consulting services to the pharmaceutical research industry. My focus is primarily in bioanalytical, information technology, and quality systems regulated under the FDA's Good Laboratory Practices (21 CFR Part 58). With a strong background in both large and small molecule analysis for pharmacokinetics, ADA, and NAb, data and system reviews from sample collection to data reporting are offered.

Conducted GLP/GCP audits of bioanalyses.

Manages Quality Control Operations in a bioanalytical laboratory.

Conducted GLP/GCP audits of bioanalyses.

A consultant as the owner of Laboratory Quality Services (LQS) since 2002. Contracts included projects spanning several days to 18 months with several clients maintained for three years or greater. Project scopes included quality assurance functions related to contract site qualification and monitoring audits (toxicology, bioanalytical, central laboratory, histopathology, veterinary diagnostics, data management, and archival), protocol, raw data, final study report audits for GLP compliant safety studies, and standard operating procedure development. Projects also included equipment and data acquisition software validation audits (Xybion, proprietary toxicology systems, and Canon digital X-ray), general system validations, pharmacostatistical software validation (Winonlin, Nonmem), bioanalytical data acquisition systems (Analyst, Softmax), bioanalytical guideline compliance, laboratory failure investigations (several), and laboratory start-ups (primarily bioanalytical laboratories and GLP training). Projects included fields of focus in pharmaceuticals (small and large molecule, biomarkers), devices (implantable pulse generator), and hybrid devices (implantable silicone drug delivery), as applied to human (primarily) and veterinary products. Responsibilities included audit conduct, advisement of corrective and preventative actions, report writing, marketing, account management, and the recruitment and management of seven support staff members (a period of four months).

Quality Assurance Officer for ABC Laboratories, Inc. in Columbia, Missouri from February 1990 to August 2002. Responsibility included Quality Assurance Unit functions for EPA/FDA GLP studies in environmental fate and toxicology (~3 years), plant and animal metabolism (~3 years), and bioanalysis of samples from phase I, II, and III clinical studies (~6 years).

Chemist for a Scientific Associates, Inc. in St. Louis, Missouri from August 1986 to February, 1990. Responsibilities included wet bench analysis, atomic absorption, infrared spectrophotometry, and HPLC analysis of pharmaceutical raw materials, finished products, and packaging components primarily for generic drug manufacturers in support of batch release and stability testing.

Research Chemist for Environmetrics, Inc. in St. Louis, Missouri from April, 1986 to August, 1986. Responsibilities included trace gas sensor research for military applications, electronic assembly of piezoelectric research instruments (and PCB in transformer oil analysis).