Peter Gillis Email & Phone Number

Saint Paul, Mn, Us

• Qualified internal manufacturing line for SARS-CoV-2/Flu A&B assay to recognize 1.1-million-dollar milestone for RADx II • Development of Qorvo internal processes for URS, FAT, SAT, IQ/OQ/PQ, and TMV for future product/process development• Implementation of GMP and manufacturing QMS requirements for 510k readiness • Maintenance of relationship with key material suppliers, third-party manufacturers, and key customers• Lead pFMEA and risk reviews for manufacturing/process improvements• Manage a team of 10 scientist and engineers responsible for new product and process introduction

Plymouth, Minnesota, United States

• Technical Transfer lead for Qorvo Biotechnologies first FDA-approved human assay SARS-CoV-2 antigen EUA submission • Led technology and manufacturing transfer and scale-up of human IVD POC assays to domestic and international external manufacturing partners to achieve production scale of >1 million units annually• Created and maintained controls systems, DMRs, BOMs, and risk analyses for internal and external manufacturing sites• Authored and reviewed URS, FAT, SAT, IQ/OQ/PQ documents for external manufacturing sites• Led troubleshooting teams to define root cause of process and assay performance challenges to maintain on schedule deliveries• Designed control systems for the Qorvo Biotechnologies portfolio• Maintained relationship with key material suppliers • Continuous improvement of QMS from implementation to successful ISO 13485:2016 Certification• Managed the technical operations, transfer, and process engineering work centers• Closed 8 CAPAs

Plymouth, Minnesota, United States

• Developed immunodiagnostic assays from feasibility through design verification for a new point of care IVD platform for the veterinary market• Responsible for manufacturing scale-up activities for initial prototype assembly line to initial market launch including resource management, scheduling, and manufacturing quality reviews• Optimized silanation and surface functionalization to improve device manufacturability and assay precision• Created manufacturing SOPs and BHRs for reagents and conjugations• Led efforts to mitigate the bubble formation in microfluidic channels and minimize impacts of assembly adhesives on assay performance

Maplewood, Minnesota

• Conducted preclinical mechanism of action testing to support clinical trials. • Completed preclinical vaccine studies for patent submission, new product development, and partner support.• Led testing efforts to measure compound activity and selection of new targets for development.• Designed and developed new assays to measure tumor specific immune responses (multiplex, qPCR, and ELISpot).• Support internal and collaborative publications and presentations through manuscript preparation, figure creation, and review

Eugene, Oregon

• Development, panel design, and validation of Firefly multiplex immunoassays• Created high throughput testing protocols for rapid evaluation of multiplex assays• Led in house testing of clinical samples and data analysis efforts to • Particle conjugation, QC analysis, and troubleshooting• Responsible for target evaluation, immunogen design, antibody screening, and pair validation for rabbit monoclonal antibody development

• Developed an ELISPOT assay for epitope mapping and to measure antigen-specific T cell responses in guinea pigs. • Created Luminex-based assay to measure guinea pig cytokine expression leading to the identification of biomarkers of congenital CMV infection.• Evaluated immunogenicity and efficacy of CMV vaccine candidates. • Characterized the effects of CMV mutants lacking virally encoded MHC homologs in vitro and in vivo.• Determined the makeup of guinea pig CMV viral particles using mass spectrometry.

• Established a model of intradermal herpes simplex virus infection in guinea pigs.• Developed immunofluorescent staining techniques to measure the innate and adaptive immune responses in guinea pig tissue. • Created custom qPCR and multiplex immunoassays to detect HSV viremia and host immune response. • Characterized the role of HSV genes (ICP6 and ICP10) in the modulation of cell type specific apoptosis using flow cytometry

• Identified a unique mechanism of HSV induced apoptosis• Characterized a viral regulator of cellular signaling pathways• Demonstrated the effects of signaling cascades on viral protein expression• Showed expression of a viral protein activates cellular stress response pathways and alters mRNA splicing and degradation

• Assisted in the development of a USDA funded rapid diagnostic testing platform porcine pseudo rabies virus. • Worked to improved antigen solubility and protein coating uniformity. • Responsible for data acquisition and analysis during testing. • Research and development of future product lines.

• Collected of samples from across the state of Minnesota to catalog the distribution of Shiga toxin producing E. coli• Conducted community outreach, education, and planning in conjunction with sample collection• Identified and characterized Shiga toxin producing E. coli using differential media, ELISA, and diagnostic PCR

Doctor Of Philosophy (Phd), Microbiology, Immunology, And Cancer Biology

Bachelor Of Science (B.S.), Microbiology, General