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.
• 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.
• 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.
• 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.

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.
• 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.
• 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