AOAC OMB Nomination Review (June 12, 2019)

Patrick M. Bird Cincinnati, Ohio 330-730-8741 pat.m.bird@gmail.com

Education

• Master of Science in Food Safety Michigan State University, East Lansing, Michigan • Bachelor of Science in Microbiology The Ohio State University, Columbus, Ohio

Technical Experience

• Owner/Technical Consultant, 2018-Present: PMB BioTek Consulting, LLC., Cincinnati, OH o Serve as Technical Consultant for AOAC INTERNATIONAL and the AOAC Research Institute ▪ Design, review and implementation of validation outlines for microbiology and analytical chemistry methods o Optimize laboratory efficiency through improvements in laboratory design, workflow and documentation o Onsite laboratory training to perform inoculation studies that meet the requirements of internationally recognized validation and verification standards o Provide guidance to diagnostic manufacturers for the development, modification and optimization of new microbiological testing methods. Directed a team of microbiologists that focused on performing evaluations of rapid alternative microbiological methods according to guidelines as specified within the AOAC PTM Program, AOAC OMA Program, ISO 16140, as well as Client Specific Verifications/Validations o Supervised the operations of the analytical chemistry department, assisting in the transition of the laboratory into a new facility and launching of an analytical research and development department (2018). o Participated in the revision to the ISO 16140 Microbiology Validation Guidelines for use in global method validation studies as part of ISO TC34/SC WG3 o Worked on developing harmonized guidelines for Microbiological Challenge Tests as part of ISO TC34/SC9 WG 19 o Developed and hosted roundtable symposia at Q Laboratories for key industry markets o Established an accreditation program for healthcare textile organization to monitor the post laundry process for healthcare laundry facilities o Designed protocols and procedures for the evaluation of re-usable medical devices for submission to the FDA including: ▪ Validation of an alternative method for evaluating nasal swab samples for presence of MRSA ▪ Evaluating the removal efficacy of biofilm formation on medical devices ▪ Assessment of surgical heater/cooler units for the elimination of Mycobacterium ▪ Served as study director for the validation of a new to market urinalysis instrument for FDA 510K approval • Microbiology R&D Supervisor; 2016-2018; Q Laboratories, Inc., Cincinnati, OH o

• Microbiology R & D Project Leader: 2007 – 2016: Q Laboratories, Inc., Cincinnati, OH o Managed validation studies for the AOAC PTM and AOAC OMA programs. o

Established a Legionella testing program that achieved CDC Elite Accreditation (2012 to present)