Immunoassays Development: Codeveloped immunoassays on platforms like Quanterix Simoa SR-X, PerkinElmer EnVision 2105, and Promega Glomax Explorer.LC-MS/MS assay development: Worked with Charles River Laboratories to develop a highly sensitive method for detection of Tofacitinib in human serum, colonic tissue and fecal samples.BioJet Capsule: Played a key role in testing and redesigning the BioJet, a needle-free ingestible capsule that delivers biotherapeutics into the small intestine. Co-authored a related patent (WO2023178354A1).RSS Capsule: Assisted in developing and testing the Recoverable Sampling System (RSS) capsule, which non-invasively samples specific GI tract areas for diagnostics, aiding in gut health and disease research.Protease/Phosphatase Inhibitor: Developed an inhibitor cocktail preserving proteins in fecal samples from Ulcerative Colitis patients, protecting target proteins for a week at 37°C.Navicap Capsule: Supported development of the Navicap, an oral delivery capsule that detects its location in the intestines and releases therapy specifically in the large intestine.LIMS Development: Built a customized LIMS system using Thermo Fisher's Core LIMS to manage the product lifecycle and sample tracking of BioJet, RSS, and Navicap capsules.

• Transformed both labs from Immediate Jeopardy (IJ) status to CLIA Compliant. • Designed, planned and performed LDT validation of 3 immunoassays for specimen validity testing and 10 immunoassays for drug toxicology screening on Beckman Coulter AU680, AU640, and AU400 platforms. • LC/MS/MS LDT method development, validation design and data analysis for a 70 drug panel on the Waters Xevo TQD platform.• Sample shipping conditions validation and development.• Development of data extraction tools for processing and reformatting instrument data into EP evaluator templates for rapid importation of large amounts of data into EP Evaluator.• Generation of EP evaluator reports for validation• Created all SOPs and a comprehensive Quality Control system from pre to post-analytical for the Toxicology department.• Hiring, supervision, training and competency assessment of 10 employees.• Prescription database creation and automated result interpretation development.• LIS validation, implementation, and interfacing.• LIS to billing system HL7 interface validation and development assistance.• Patient result report development and validation.• Training of account managers and sales personnel on education of our clients regarding specimen collection, storage and shipping.

• Transformed both labs from Immediate Jeopardy (IJ) status to CLIA Compliant. • Designed, planned and performed LDT validation of 3 immunoassays for specimen validity testing and 10 immunoassays for drug toxicology screening on Beckman Coulter AU680, AU640, and AU400 platforms. • LC/MS/MS LDT method development, validation design and data analysis for a 70 drug panel on the Waters Xevo TQD platform.• Sample shipping conditions validation and development.• Development of data extraction tools for processing and reformatting instrument data into EP evaluator templates for rapid importation of large amounts of data into EP Evaluator.• Generation of EP evaluator reports for validation• Created all SOPs and a comprehensive Quality Control system from pre to post-analytical for the Toxicology department.• Hiring, supervision, training and competency assessment of 10 employees.• Prescription database creation and automated result interpretation development.• LIS validation, implementation, and interfacing.• LIS to billing system HL7 interface validation and development assistance.• Patient result report development and validation.• Training of account managers and sales personnel on education of our clients regarding specimen collection, storage and shipping.

• Reduced average data analysis time from 3 hours to 30 minutes through development and validation of Ascent LCMS data analysis methods. • Data innovations server installation, setup, management, and blood chemistry auto verification rules writing/validation. • LIS validation/implementation/management at 13 labs for Blood Chemistry, Hematology and Toxicology. • Development of auto flagging system for prescription/LCMS result concordance/discordance for 56 analytes. • Instrument interfacing for: Roche Cobas 6000, Sysmex XN, Beckman Coulter AU400 and Au640, Agilent 6460 and 6420, Cell-Dyn Ruby, and the Roche Urysis 1100. • Implementation and management of Bio-Rad Unity Real Time and Bio-Rad Unity connect QC software for tracking blood chemistry and LC/MS/MS QCs. • Development and implementation of automated assessment of sample stability for toxicology reporting.• AD-HOC SQL report development for billing and tracking of lab statistics.• Sample tracking system implementation.

• Preclinical and Phase 1 Clinical Trial work. Was responsible for aiding in the development of IRB reports and communications.• Developed an immunoassay (immunofluorescent staining) for 3D modeling and quantitation of biofilms via confocal laser scanning microscopy as well as simultaneous visualization and counting of live/dead Burkholderia cepacia after administration of PPMOs targeted to essential biofilm genes and appropriate antibiotics.• Contributed figures to and developed anti-biofilm PPMOs for patent US9790495B2.• Created a crystal violet biofilm staining assay for rapid screening of newly developed PPMOs using a BIO-TEK Synergy HT 96 well plate reader. • Minimal Inhibitory Concentration (MIC) studies, Growth curve studies. • Polymorphonuclear Neutrophil (PMN) studies with PMNs from patients with cystic fibrosis (purification, apoptosis/necrosis flow cytometry studies, phagocytosis and killing with biofilm producers with the aid of PPMOs).• PPMO target development via National Center of Biotechnology Basic Logical Alignment Search Tool (NCBI BLASTs).• Confocal microscopy (Zeiss LSM 510 META confocal/ multiphoton and Perkin Elmer Spinning Disk) experience.• Full slide fluorescence imaging microscopy (Zeiss Axio Scan.Z1) experience.• Nikon Eclipse TS100 Inverted Fluorescent Microscope experience.• Bitplane Imaris was used for 3d modeling of biofilms from images obtained using confocal microscopy • Other imaging software use: Zeiss Zen for analysis of scanned slides, Autoquant X for deconvolution, CZI to TIFF Batch Converter, Aperio ImageScope, ImageJ, Nikon NIS Elements BR and Zeiss LSM software for linear unmixing.

High Pressure Liquid Chromatography / Tandem Mass Spectrophotometer (HPLC-MS/MS or LC/MS/MS) Operator and Chromatography First Reviewer. Ameritox Ltd. offered urine analysis for the purpose of pain medication monitoring of patients for medical doctors. • Reviewed samples that were being tested for benzodiazepines, opiates, fentanyl, and gabapentins.• Made calibration curves for every drug being tested.• One of two individuals that were trusted to make the mobile phase solutions for all HPLCs.• Development of automated worklist creation for LC/MS/MS batches. • Programs used for chromatography analysis and mass spec monitoring included Thermo Scientific’s Aria, LC Quan and Xcaliber. • Responsible for weekly maintenance on instruments.• Became familiar with College of American Pathologists (CAP), Commission on Office Laboratory Accreditation (COLA) accreditation process and Clinical Laboratory Improvement Amendments (CLIA) certification requirements. • Thorough understanding of the confidentiality of client information in regards to the Health Insurance Portability and Accountability Act (HIPAA).

The purpose of this project was to scale up human hemoglobin production from BL21(DE3)/pHb0.0TM1hug cultures grown in test tubes to large scale (multiple liters)human hemoglobin production with cultures grown in a bioreactor. By developing a largescale human hemoglobin production method we hoped to show that using E coli thatcoexpress the P. shigelloides heme transport system genes and the human hemoglobingenes is an economical method of producing recombinant human hemoglobin for use as ablood substitute. Our previous work suggested using a heme transport system to moveheme into the cell created a large intracellular heme pool which allowed over 10 timesmore hemoglobin to be produced. • Managed and trained 4 lab members to ensure the efficient operation of a Bioflo 110 bioreactor. • Publications from my master’s thesis work: o Smith BJ, Gutierrez P, Guerrero E, Brewer CJ, Henderson DP. Development of a method to produce hemoglobin in a bioreactor culture of Escherichia coli BL21(DE3) transformed with a plasmid containing Plesiomonas shigelloides heme transport genes and modified human hemoglobin genes. Appl Environ Microbiol. 2011 Sep;77(18):6703-5.o Varnado CL1, Mollan TL, Birukou I, Smith BJ, Henderson DP, Olson JS. Development of recombinant hemoglobin-based oxygen carriers. Antioxid Redox Signal. 2013 Jun 10;18(17):2314-28. o Henderson DP, Smith, BS. Methods of Producing Human Hemoglobin in a Bioreactor. US patent pending. Application number 14/164,738. Currently under review.• Master’s thesis and project.• Techniques used during project:o Bioreactor operation and Maintenance.o Analyzed approximately 200,000 data points per run per week.o Batch/Constant-rate Feeding, Stepwise Glucose Feeding and Mass Flow Equation Based Glucose Feeding calculations.o Plasmid isolation, purification, and quantification.o Constructions of plasmid constructs for expression of exogenous genes.

• Taught Human anatomy and Freshman Biology 1 and 2 with up to 24 students per lab.• Prepared lab lectures and tutoring sessions.• Graded tests, quizzes, homework and formal lab write-ups.

• Communicated in English in a way that comprehension could be conveyed to native Japanese speaking students without the aid of Japanese.• Students ranging from pre-K to high school age.

Prometric Testing Center Manager and Test Administrator.• Scheduled staff and determined testing schedule.• Administered exams and ensured that all client testing regulations were followed for over 300 different clients.• Monitored logs to ensure that all regulations were followed by the staff.• Held Regular meetings to ensure that all staff members were aware of any new clients or changes to existing client’s regulations.

• Managed a Windows NT small business server and 12 associated computers for analysis of student test results and record keeping• Tutored students in the following subjects: English, Algebra, Trigonometry, Calculus, Chemistry and Biology

Streptonigrin anti-colon cancer drug research.• Used GC/MS to quantify if changes made to the synthesis protocol for the pyridine ring-C of Streptonigrin resulted in improved yields above the 28% yield achieved from Diels-Alder reactions.