John Grace Email & Phone Number

Abbott Park, Illinois, Us

Resource Team Leader: Managed team whose role is improving efficiency in elevated complaint investigations.• Advised employees on experimental design and data analysis• Led effort to analyze data for complaint investigation metrics as well as for use as data sources for investigations. Implemented TPS metrics Power BI report for communication to management and other teams.• Coordinated with Field Quality to improve understanding regarding complaint investigation process as well as disagreements regarding individual investigations• Managed technical analysis of FQA complaint trending required by IVDR. Completed investigations of non-conformances identified

Abbott Park, Illinois, Us

Systems Integration Team Leader: Developed experimental plans, requirements, verification studies and completed verification summaries that led to the successful launch of the Alinity mp pre-analytic system in July of 2021. • Developed and executed experimental plan for characterization of samples used for HPV and sexually transmitted disease assays, to create mixing and fluid transfer protocol.• Worked together with outside vendor and internal cross-functional team to develop verification plan, verification protocols, verification records and verification summary reports.• Successfully conducted internal assay verification studies.• Used fluid handling skills and machine programming to create settings for Hamilton pipettor • Developed use cases for the instrument during development and tested them on prototypes.• Created test solutions for samples, interfering substances, and developed method for utilizing remnant samples for verification testing.SARS-COV-2 Assay: Designed data reduction and prepared application specification for SARS-CoV-2 assay successful emergency use launch and subsequent IVD and 510K launches.• Data Reduction subject matter expert for emergency development of the RealTime SARS-COV-2 assay. • Created application specification files and application disks for development and emergency distribution.• Conceived and implemented solution to optical error discovered after market launch. This saved Abbott Molecular from reformulating the assay, saving 3.9 MM tests in inventory, and allowing production of an additional 5.5 MM tests minimum. Impact of $235 MM• Awarded Division President’s Award• Awarded 2021 Special Recgnition from CEO Robert Ford

Abbott Park, Illinois, Us

Developed and managed requirements and feature characterization for successful launches of m2000 v8.0 (March 2015) and v8.1 (October 2015).• Managed requirements, documenting version descriptions, creating detailed feature descriptions and quality documents in APLM• Successfully worked with marketing, quality, regulatory and a group of third-party programmers to create m2000 v8.1.

Abbott Park, Illinois, Us

• Worked with director, OEC, scientific affairs and marketing to set up a group of leading innovative medical diagnostic facilities in both core lab as well as blood banking worldwide to work with Abbott Diagnostics R&D. These Centers of Innovation (CoI) were used as a resource during development of the Alinity s and Alinity i systems.• Facilitated input from CoI’s to R&D teams, created content, presentations and conducting meetings via teleconferences, site visits, expert panel meetings and small studies. • Arranged for guest speakers from the COIs to present at R&D all employee meetings. • Created a customer site visit program for R&D scientists and engineers to visit customer sites to better understand challenges faced by our customers to gain insights into design implementations and new product ideas. I created training materials, facilitated selection of customer sites, provided training to R&D participants, and then led meetings at Abbott so the Scientists and Engineers could share their findings. I created a framework for capturing and collating the ideas and insights captured across all the site visits.• Performed a technical market comparison for Immunoassay Analyzers for low test volume laboratories for an R&D senior director. Captured and analyzed technical information for all low test volume Immunoassay analyzers then working with a cross functional team, used advanced statistical techniques to rank key features then rank the analyzers.

Abbott Park, Illinois, Us

Technical Support: Provided training and support that ensured success of the m2000 system.• Created and provided m2000 system training for customers and Abbott technical and non-technical personnel. • Provided top level support for m2000 worldwide. • Developed and implemented troubleshooting training and tools for use by front line support.• Successfully provided support for investigations at customer and clinical sites either remotely or on site.• Created applications training guides for new assays launched on the m2000.• Launched accessory parts for the m2000 system (battery backup power supply and bar code scanner)• Granted an EU patent for discovery of a means of avoiding thermal overshoot during thermal cycling Project Manager: Successfully managed launch of m2000rt Optical Calibration Kit and managed characterization of m2000rt system prior to m2000 system launch in June 2005.• Managed development of spectral calibration accessory used in the m2000 cycler reader.• Lead team responsible for characterization of new Abbott real-time PCR instrument. My team successfully completed Thermal, Optical, and long-term characterization studies prior to launch.Systems Integration: Investigated physical, optical and assay variables for new real time PCR cycler reader. Developed test methods and experimental designs, analyzed data and made recommendations to cross functional teams. • Created a novel solution to dye interaction problems by utilization of a drop in filter set that separated the dyes across the useable spectrum of the detector. • Used test method development, analytical and data processing skills to evaluate multiple thermalcycler/reader systems. Systems and fluorescent dyes used were characterized and evaluated.

Abbott Park, Illinois, Us

: Successfully led document routing and finalization team. • Successfully led a team that facilitated freeze/thaw updates to over 580 MF and MS documents. Created a process for document (MF, MS) user input where document owners, document signatories and document editors meet to work out document edits.• Led team of four to complete statistical method data collection ahead of schedule. Coordinated archival data retrieval and compilation for statistical review as needed for FDA submissions. • Led team of four people responsible for remediation of all existing frozen inventory in all ADD LC site bin locations. • Awarded Site Operations Award of Excellence• Awarded Corporate VP Team Award

Abbott Park, Illinois, Us

ASF (Generic Glucose Strips): Successfully led team evaluating coating and strip thickness using spectroscopic and laser profiling methods. • Identified and applied imaging methods to prototype strips. • Characterized materials such as reagent viscosity, surface topography, thermal, spectral and physical and dimensional properties. • Tested reagent stabilities, whole format, full and partial chemistries, with and without stabilizers. • Investigated numerous coating technologies for strip manufacturing.SpectRx (Transdermal Poration): Developed methods to image and measure laser pores and skin damage (both in vivo and in vitro). Conceived and tested novel interstitial fluid harvesting technique. • Characterized the poration process, using white light and confocal microscopy, analog and digital video, film and digital cameras. Collaborated with programmer to create software to analyze pore depth. • Conceived a novel Interstitial Fluid harvesting system patented by Abbott. • Team member representing Abbott on site in all project clinical testing. • Awarded 1998 ADD Associate Scientist of the YearNon-Invasive Glucose Monitor:• Prepared samples, interfaced equipment to human volunteers, interfaced sample handling to instrumentation. • Created panels of possible interfering substances purifying using chromatography and lyophilizing purified extracts.Glucose Testing Market Review: Collaborated with other team members to gather critical market information derived from patent mapping, competitive research and analysis, glucose market history, science modeling, and customer analysis to successfully develop the Abbott Glucose Business Plan.• Worked with expert physician consultants using expert panels, shadowing, and concept review to identify market conditions and trends affecting ADD’s diabetes market opportunity.• Developed databases for tracking companies, technologies, patents, and outside contacts. Helped assess all key technologies.

Abbott Park, Illinois, Us

Smart Structures (Machined Membranes): Conducted research into replacement technologies for nitrocellulose membranes for use in dry immunoassays• Co-invented a novel micro-machined membrane for immunodiagnostic tests. • Identified membrane manufacturing/replication techniques and strip assembly methods.• Completed key comparisons of reagent immobilization on nitrocellulose, polystyrene, and Smart Structures using RIA and radiological imaging. • Developed techniques for reagent application and various membrane test systems.New Labels Technologies: Investigated novel detection labels for use in dry immunoassays. • Met goal of 1µIU/ml TSH in serum sample. • Performed sample preparation, reagent preparation, microscopy, particle evaluation, gel filtration/separation and data analysis.Hendrix (Solid-State Immunoassay): Conducted research for a novel capillary device for staging of homogenous immunoassays using CAMIA technology.• Performed the device imaging and microscopy, assay development, spectroscopy and gel separation of reagents. • Applied novel technologies learned from Hendrix project to develop a new urine collection device.