Professional Strengths
Extensive experience in writing and editing technical documentation
- Ability to reduce large amounts of data into concise, meaningful documents suitable for submission to FDA
- Writing experience includes validation protocols and reports, Quality System documentation, manufacturing documentation, and SBIR grants
- Reputation for clear, concise written communications and for delivering high-quality results on time
Strong scientific background
- Solid background in immunology, HIV/AIDS, prostate cancer, colon cancer, autologous cell therapy, and bone metabolism
- Thorough understanding of scientific methods
- Skilled in conducting online searches and in screening, evaluating, and summarizing pertinent literature
Proficient in managing projects
- Highly organized and adept at planning, coordinating, and completing projects
- Instructed a class in manufacturing project management for the Institute of Validation Technology (2006)
- Substantial experience in constructing timelines and managing projects
My experience will help to shorten your project's timeline!
Experience
Freelance Consultant, 2003 – present
- Master validation planning, preparation of validation protocols and reports
- Quality System design and documentation
- Regulatory project management
- Grant writing, administration, and electronic submissions
Ostex International, Inc., 1992 – 2002
Ostex made diagnostic tests using either serum or urine to detect levels of type I collagen. The tests are used to monitor response to osteoporosis therapy. Ostex was acquired by Inverness in 2003.
Positions held: Manufacturing Engineer, Manufacturing Manager, Director of Manufacturing, and
Vice President of Manufacturing
- Responsible for construction of 2 manufacturing plants (microtiter plate and point-of-care plants)
- Specified and validated all major manufacturing equipment
- Recruited and trained manufacturing staff
- Created and managed the manufacturing documentation system
- Approximately 700 documents including SOPs, batch records, test methods, and purchase specifications
- Authored approximately 70% of the documents; reviewed and approved 100%
- Served on management committee to optimize the corporate business strategy
Genetic Systems, 1984 – 1992
Genetic Systems makes many different clinical diagnostic tests (eg, HIV, HIV II, HBsAg, Legionella) and supports those tests with custom software. Genetic Systems is now owned by Bio-Rad.
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 facility 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) in accordance with corporate goals and in compliance with regulatory requirements
Department of Oncology, University of Washington, 1981 – 1984
Research Technologist
- Conducted 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 and Credentials
- Bachelor of Science in Fisheries, University of Washington
- Project Management Course, American Management Association
- Basic Management Course, Battelle
- Certified as an English as a Second Language (ESL) tutor
Advisory Board Experience
- Biotechnology Program Advisory Board, Seattle Community College (15 years)
- Medical Device Advisory Committee, International Society of Pharmaceutical Engineers (3 years)
Professional Affiliations
- Organization of Clinical and Regulatory Associates (ORCA)
- American Medical Writers Association (AMWA)
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