Objective
A position that uses my experience in quality, production and management to help your company achieve its goals
Summary
- Experience in product development; product transfer; reagent process scale-up; process and
facilities validation; software and diagnostic kit quality assurance; preproduction quality assurance;
manufacturing; and facilities design, start-up, and qualification
- Experienced in managing to current Quality Systems Requirements
- Excellent managerial, organizational, motivational and interpersonal skills
Experience
2003 to Present
Independent consultant helping diagnostic and biotherapeutic companies achieve their outsourcing, production and compliance goals.
- Serve on one client’s general management team
- Perform grant writing and assist in business development activities
- Technical writing to support Master Validation planning and facilities validation for biotherapeutic
products
- Acting head of Quality Assurance and Regulatory project coordinator for one client
- Outsource manufacturing and conduct compliance and capability audits
1992 to 2002
Ostex International, Inc.: Ostex made diagnostic tests using either serum or urine to detect the levels of type I collagen. Ostex was acquired by Inverness in 2003. The tests are used to monitor response to osteoporosis therapy.
Positions held: Manufacturing Engineer, Manufacturing Manager, Director of Manufacturing and Vice President of Manufacturing
- Responsible for construction of 2 manufacturing plants (a 7,000 sq. ft. microtiter plate product plant
and a 14,500 sq. ft. point-of-care device manufacturing plant)
- Specified and validated all major manufacturing equipment
- Created and managed the manufacturing documentation system
- Recruited and trained manufacturing staff
- Served on management committee to optimize our corporate business strategy
1984 to 1992
Genetic Systems: Genetic Systems makes many different clinical diagnostic tests and supports those tests with custom software.
Positions held: Development Biologist, Senior Technician, Project Coordinator, and Quality Assurance Manager
- Participated in the development of 2 enzyme immunoassays
- Coordinated the generation of information required for product and establishment license approvals
for process modifications to an FDA approved product.
- Participated in the design and facilities validation of a BL-3 containment laboratory.
- Transferred medical device software, an enzyme immunoassay, and a rapid synthetic peptide-based
immunoassay from Research and Development to Manufacturing
- Directed the Quality Assurance department (reagent and software QA) to achieve corporate goals
and satisfy regulatory requirements
1981- 1984
Research Technologist
Department of Oncology
University of Washington
- Conducted experiments, monitored animals, and reported the results of in vivo and in vitro
adoptive chemoimmunotherapy experiments
- Developed T- lymphocyte-depleted mouse colony
- Participated in the investigation of the in vivo role of Interleukin-2
Education
Bachelor of Science in Fisheries, University of Washington
Additional Training
Dry Suit Certification (National Oceanic and Atmospheric Admin.)
Project Management (American Management Association)
Basic Management (Battelle)
Process Filtration (Society of Manufacturing Engineers)
Biohazards in the Laboratory (Johns Hopkins)
Fermentation Microbiology (American Type Culture Collection)
Lateral Flow Immunodiagnostic Devices (Millipore)
Certification in Materials Requirements Planning (American Production and Inventory Control Society)
Advisory Board Experience
Seattle Community College Biotechnology Program Advisory Board (15 years)
International Society of Pharmaceutical Engineers Medical Device Advisory Committee (3 years)
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