PHARMXTRAX provides expert advisement services to navigate the development life cycle of pharmaceuticals, single-use manufacturing equipment and medical devices.

• Serve as the lead technical officer and SME for all pharmaceutical and biotech operations.• Provide detailed, expert scientific advisement and management for CMC, clinical manufacturing, analytical development, extractables & leachables programs and regulatory submission projects for all of Health Sciences. • Directly interact with clients to develop and expand technical and business relationships with an emphasis on resolving technically demanding issues in pharmaceutical development projects.

NSF Health Sciences provides contract auditing, consulting, testing and training to pharmaceutical, biotechnology and medical device clients worldwide. The Health Sciences division employs approximately 200 people with laboratories in Brazil, China, Peru, Germany and the United States.• Oversee all pharmaceutical and medical device laboratory operations for NSF worldwide.• Led the strategic development for each individual facility as well as the full network of Health Sciences laboratories.

• Responsible for the day-to-day technical and business operations of the laboratory.• Serve as a technical project resource for multiple pharmaceutical clients developing novel and complex therapies.

Pharmalytica Services was a specialized GLP/GMP contract analytical testing laboratory providing unique solutions to technically challenging issues for the pharmaceutical and biotechnology industry. Pharmalytica was acquired by NSF International in February 2011.• Oversee all Pharmalytica Services operations• Direct and manage the daily business activities of the company• Orchestrated the sale of Pharmalytica to NSF International in 2010 - 2011.

• Manage and direct FDA-regulated formulation, analysis, regulatory compliance and outsourcing activities for Purdue at contract vendor sites throughout North America and Europe• Managed $17M annual outsourcing budget• Establish contracts and master service agreements with contract vendors

Research Scientist/Principal Research Scientist, February 1997 – August 2000• Supervisor of GLP Analytical R&D laboratory supporting toxicology • Coordinated internal research and outsourced activities among analytical chemistry, toxicology, regulatory compliance and CROs to ensure the completion of project objectives• Represented technical and regulatory aspects of GLP Analytical R&D on project teams to successful NDAs for HIV, oncology and cardiovascular productsStaff Scientist / Sr. Staff Scientist, (December 1991 – February 1997)• Managed daily operations for GMP and GLP analytical laboratories supporting both toxicology and method development, validation and release of clinical supplies• Primarily responsible for chromatographic methods development and validation for the analysis of toxicology dose formulations and physical characterization of drug substanceLaboratory Technician / Associate Scientist (August 1987 – December 1991)• Responsible for chromatographic analysis of GLP samples in support of toxicology• Routine analysis of drug substance and dosage forms in support of clinical studies and product shelf-life determination