Experience

Arlington Scientific, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Technical Production Manager

  • Jul 2017 - Present

  Manage the Technical Production laboratory. Schedule and plan complex biotechnical manufacturing processes. Ensure that laboratory personnel are properly trained and follow cGMP for medical device manufacturing. Prepare and design documents and procedures for manufacturing processes, validations, and technology transfers. Direct trouble shooting, process improvement, validation, and technology transfer projects. Collaborate with other departments to achieve project completions.

• Technical Production Scientist

  • May 2013 - Jul 2017

  Prepare the reagent components of the company's agglutination assays and multiplexed allergy ELISA's consisting of: Rapid Plasma Reagin, Rheumatoid Factor, C-Reactive Protein, Rubella Virus, Heterophile Antibody, Staph aureus, Anti-Streptolysin O, and more than 100 different allergens. Conduct incoming, in-process, and finished goods Quality Control inspections and testing. Participate in process development, validation, technology transfer, and trouble-shooting projects. All activities are conducted within FDA Quality Systems guidelines. Show less



Springville City Corporation

• Springville, Utah

• Professional - Temporary (as a Microbiology Consultant)

  • Sep 2012 - Mar 2013

  Designed phase-contrast microscopic examination and data analysis methods for the wastewater treatment facility. Designed phase-contrast microscopic examination and data analysis methods for the wastewater treatment facility.



Arlington Scientific, Inc.

• Provo, Utah Area

• Scientific Production Specialist

  • 2001 - 2011

  Performed allergenic antigen immobilization on a solid phase (coatings) for Enzyme Immunoassays (ELISA's). Prepared Urease anti-human IgE conjugate for ELISA utilizing column chromatography and UV-Vis spectrophotometry. Dialyzed protein solutions. Concentrated allergen extracts by use of an Amicon stirred cell. Participated in the technology transfers and manufactured the following latex agglutination immunoassays and components: Heterophile Antibody, Rubella, Lupus, C-Reactive Protein, S. aureus, Rheumatoid Factor, and defibrinated plasma. Troubleshooted technical manufacturing processes. Prepared 125I anti-human IgE conjugate for radioallergosorbent tests (RAST). Prepared RPR for the Syphilis Card Test. Performed blood tests with latex agglutination methodologies. Collaborated in a medical device clinical trial and the successful preparation of a FDA 510(k) submission for a Treponema pallidum Hemagglutination immunoassay (TPHA). Conducted weekly technical meetings and briefings. Integrated processed imaging data into a database. Performed testing and evaluations of multiplexed ELISA products and stored results electronically and on hard copy. Developed and administered FileMaker data-bases. Modified manufacturing equipment and processes to improve efficiency. Provided customer technical assistance for CLIA regulated products. Performed quality control inspection and testing. Prepared GMP documents. QC tested lateral flow devices. Show less



Meridian Bioscience Inc.

• United States
• Medical Equipment Manufacturing
• 400 - 500 Employee

• Scientific Production Specialist

  • Jun 1999 - Feb 2001

  Evaluated the use of Image-Pro Plus image analysis software for documenting the captured fluorescence microscopy images of Gull Laboratories immunofluorescent assays (IFA's). Researched and evaluated fluorescence microscopes, CCD cameras, and image analysis software from different vendors and recommended the purchase of the system that was the best value for the company. Trained in Design Control and writing validation procedures. Wrote and performed validations. Troubleshooted IFA processes including Epstein-Barr Virus (EBV) antigen expression in human B-Cell lines isolated from Burkitt's Lymphoma. Show less



Gull Laboratories, Inc.

• Salt Lake City

• Virology Department Supervisor (and other positions)

  • Jun 1986 - May 1999

  Analyzed and designed experiments to correct problem areas of production processes in the IFA diagnostic kit product line and Epstein-Barr Virus antigen production for the the ELISA product line. Trained in project management. Supervised the activities of 6 to 8 technologists in maintaining cell cultures, virus propagation, and harvesting of virus infected cell cultures for the manufacture of immunodiagnostic test kits. Ensured that the department was properly trained and followed Good Manufacturing Practices (GMP). Coordinated development projects for improving department productivity such as scale up of B-cell cultures and virus production, and modification and validation of production processes. Viruses included EBV, HSV, CMV, and VZV. Coordinated the technology transfers of processes for new product introductions. Prepared and/or presented status reports and briefings of lab activities and projects. Prepared detailed validation reports of process modifications. Combined information technology with GMP and laboratory procedures to improve traceability, trending, and manufacturing efficiency. Conducted product development projects involving EBV cell culture techniques scaled to 36L stir flasks and TFF, and immunological profile studies involving IFA’s, PAGE, and Western blot. Responsible for the mass production of monolayer cell culture by microcarrier technology. Conducted product development projects concerning the optimization of EBV antigen expression in cell culture. Show less