Nick Letourneau, Phd Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Leading Clients' product development programs for combination products and IVDs with a particular focus on Design Controls, Risk Management, and Quality.

Morrisville, North Carolina, United States

Cary, North Carolina, United States

Prepare and implement business plans for future at-home diagnostic test products. Manage intellectual property for core technology and products. Create and execute multi-year product development pipeline. Supervise eight staff in materials engineering, diagnostics, and therapeutics.● Authored EUA submission for COVD-19 lab-based high-throughput antigen test and was responsible for overseeing assay verification and validation with clinical samples in BSL2+ lab.● Established commercial-scale manufacturing process for DNA Nanostructures utilizing up to 250 oligonucleotides including incoming raw material QC, annealing processes, purification, and lot release.● Designed prototype antibody-free lateral flow assay for COVID-19 in 3 months.● Won 2021 Advanced Lateral Flow Conference Rapid Testing Innovation Award.

Morrisville, North Carolina, United States

Oversaw cross-functional team of six scientists, quality engineers, and marketing experts. Project-managed BioMedomics COVID-19 antigen test development initiative. Introduced multiple process enhancements to existing BioMedomics products.● Fixed SickleScan(TM) product manufacturing process providing consistent production for the first time.● Improved SickleScan(TM) product quality assurance procedures lowering quality control failures.● Built semi-automated manufacturing line producing 2M annual lateral flow tests.● Transferred semi-automated manufacturing process to CMO with fully automated manufacturing process capable of producing more than 10M yearly lateral flow tests.

Raleigh, North Carolina, United States

Invented, introduced, and launched SipChip(TM) 30-second miniaturized lateral flow test identifying drugs in more than 100 beverages. Communicated with customers and translated feedback into actionable product improvements and enhanced marketing strategy Analyzed research and development and manufacturing facilities in U.S., Canada, and Europe. Managed 12 R&D staff at labs in California and North Carolina. Oversaw expansion of DxChip(TM) diagnostic platform for at-home testing products.● Granted six patents in five years for Undercover Colors core technology.● Co-presented with CEO during SipChip™ product launch media tour securing more than 10 interviews with major media outlets.● Launched the SipChip™ product generating $250K in revenue in first year.● Developed five lateral flow assays for DxChip™ platform to use in at home testing products.● Managed contract manufacturing organizations and raw material supply chain for production of more than 100K units in first year of production.● Negotiated multi-year agreement reducing CRO labor costs by 15%.● Established QA/QC procedures for SipChip™ product at three U.S. manufacturing sites.● Evaluated and on-site audited eight contract manufacturing organizations

Raleigh-Durham, North Carolina Area

Designed two chemical tests for drug detection in beverages. Studied sensitivity, specificity, and stability of new assays.● Established R&D facility including site selection and equipment procurement for diagnostic assay development and device engineering in 4 months.● Designed and implemented Laboratory Notebook and Document Management system for R&D team to arrange hundreds of experimental reports and thousands of data files.

Durham, North Carolina, United States

Conducted rational design and synthesis of new antiviral compounds based on review of molecular modeling software, crystallography data, and structure-activity relationship. Led team and interdepartmental communication to advance projects.● Managed six co-op chemists to conduct research on novel synthetic chemistry reactions for publication.● Synthesized more than 30 new structures for drug discovery screening.

Morrisville, North Carolina, United States

Produced platform for high-throughput molecular assay using animal whole blood samples. Advanced project from concept to working model.● Increased testing output by 100% by lowering time required for lysis and denaturation steps of molecular assay.● Reduced testing expenses by 300%.

Kalamazoo, Michigan, United States

Adapted academic research to meet industry needs by designing photo-click chemistry-based linkers for bioconjugation of small molecules and peptides to carrier proteins resulting in increased control of modification site on proteins, rapid characterization of conjugates, and raising reaction efficiency and throughput.● Synthesized new photo-click chemistry linker with tunable activation wavelength for conjugation of peptides to carrier proteins.● Produced three new model peptide-carrier protein constructs for vaccine manufacturing studies.

Doctor Of Philosophy - Phd, Organic Chemistry

Bachelor Of Science - Bs, Biomolecular Science