David Gauthier Email & Phone Number

Orange County, California, United States

● Portfolio Oversight: Owner of the Infectious Disease Molecular QC franchise with 100+ products, ensuring effective product lifecycle management● Global Strategy: Set vision and developed the global portfolio strategy, including a 10-year LRP, a 5-year roadmap and an NPD pipeline. Lead business reviews for senior leadership to inform strategic discussions● Strategic Initiatives: Guide global market development and strategic diversification initiatives. Drive global expansions… Show more ● Portfolio Oversight: Owner of the Infectious Disease Molecular QC franchise with 100+ products, ensuring effective product lifecycle management● Global Strategy: Set vision and developed the global portfolio strategy, including a 10-year LRP, a 5-year roadmap and an NPD pipeline. Lead business reviews for senior leadership to inform strategic discussions● Strategic Initiatives: Guide global market development and strategic diversification initiatives. Drive global expansions through targeted business development, cultivating impactful B2B partnerships. Contribute to M&A evaluations for Go/No-Go decisions● Market Analysis: Conduct global market segmentation and customer targeting. Create and present business cases and financial models for new product launches. Serve as a commercial lead in cross-functional Core Teams for NPD execution. Ensure compliance with FDA, CLIA, IVDR, CAP & ISO 15189 regulatory standards● Launch Excellence: Successfully launched and managed the NPI of 6 product families and rationalized 2 within a 3-year timeframe. Define GTM strategies and commercialization plans for launch excellence. Developed a Sales Cycle Success Evaluation process with KPI to gauge post-launch execution quality. Review content for outbound marketing campaigns● Customer Focus: Conduct worldwide VOS, VOC and Gemba initiatives for insights into the business and user experience, workflow & needs● Global Thought Leadership: Propose innovative scientific studies to KOL globally and draft articles, posters & presentations to enhance the organization's scientific & thought leadership● Industry Engagement: Create educational and training materials for internal & external stakeholders. Attend global scientific conferences to stay updated and foster industry relationships. Collaborate in the preparation & moderation of Scientific Advisory Board meetings● Leadership: Mentor to a Product Manager engaged in other Molecular spaces, such as NIPT, Biopharma and Oncology Show less

Orange County, California, United States

● Managed diverse Infectious Disease and Genetic Disease diagnostics portfolios, including 3 In Vitro Diagnostics (IVD) assays, 70+ Analyte Specific Reagents (ASR) & General Purpose Reagents (GPR), Real-Time PCR (RT-PCR) & Point of Care (POC) instruments, software, consumables and automation● Successfully launched 5 ASRs and introduced 2 software versions● Core Team member for assays, ASRs and instruments NPD● Conducted VOC with KOL; Supported domestic & global Sales teams●… Show more ● Managed diverse Infectious Disease and Genetic Disease diagnostics portfolios, including 3 In Vitro Diagnostics (IVD) assays, 70+ Analyte Specific Reagents (ASR) & General Purpose Reagents (GPR), Real-Time PCR (RT-PCR) & Point of Care (POC) instruments, software, consumables and automation● Successfully launched 5 ASRs and introduced 2 software versions● Core Team member for assays, ASRs and instruments NPD● Conducted VOC with KOL; Supported domestic & global Sales teams● Collaborated with Scientific Affairs on strategic studies● Participated in global scientific conferences & tradeshows● Presented strategic insights and tactical plans to the CEO during business reviews and sales meetings Show less

Orange County, California Area

● Generated content for educational and promotional campaigns● Conducted competitor research and created supporting documents and presentations● Delivered internal technical training, including hands-on laboratory sessions● Established and nurtured internal & external collaborations● Attended tradeshows, business reviews and sales meetings

Orange County, California Area

● Supported clinical laboratories globally with Molecular (quantitative qPCR & qualitative RT-PCR) and Serology (ELISA and IFA) assays (Laboratory-Developed Tests (LDT), 510(k) & CE-IVD)● Provided expertise in instrument engineering & software, overseeing servicing needs in the field● Managed a territory composed of 12 U.S. states and 40+ accounts● Cross-functional collaboration with Sales & Field Service Engineers, contributing to portfolio upselling● Mentored 3 Field… Show more ● Supported clinical laboratories globally with Molecular (quantitative qPCR & qualitative RT-PCR) and Serology (ELISA and IFA) assays (Laboratory-Developed Tests (LDT), 510(k) & CE-IVD)● Provided expertise in instrument engineering & software, overseeing servicing needs in the field● Managed a territory composed of 12 U.S. states and 40+ accounts● Cross-functional collaboration with Sales & Field Service Engineers, contributing to portfolio upselling● Mentored 3 Field Application Scientists● Delivered comprehensive customer assistance, demos, training, installations, validations, troubleshooting, workflow recommendations, preventative maintenance & software support● Attended conferences globally, participated in booth operations● Engaged KOL in collaborations● Prepared and delivered educational presentations to customers & Sales● Provided training to Field Application Scientists, international distributors & Sales Executives● Conducted scientific studies and experiments in the laboratory to inform product performance● Offered suggestions for portfolio expansion & improvements based on VOC collection Show less

Orange County, California Area

● Same as above but also covering AMER, EMEA, LATAM & APAC● Managed international distributors● Engaged customers in English, French and Spanish

Orange County, California Area

● Improved ELISA and IFA products by introducing new antigens, antibodies and matrices● Mentored 2 laboratory technicians● Conducted studies to optimize GMP-regulated processes, leading to increased yields and reduced production costs; Leaned GDP documents● Optimized ELISA and capture assay performance on the Triturus ELISA automated system● Drafted feasibility studies, validations and SOP to ensure process efficiency and compliance● Troubleshot and identified root causes of… Show more ● Improved ELISA and IFA products by introducing new antigens, antibodies and matrices● Mentored 2 laboratory technicians● Conducted studies to optimize GMP-regulated processes, leading to increased yields and reduced production costs; Leaned GDP documents● Optimized ELISA and capture assay performance on the Triturus ELISA automated system● Drafted feasibility studies, validations and SOP to ensure process efficiency and compliance● Troubleshot and identified root causes of issues in ELISA and IFA-based assays● Successfully addressed the company's highest yearly scrapping costs● Worked with pathogens in a GMP-compliant environment● Investigated and resolved customer complaints● Represented Operations in Core Teams● Presented findings to senior leadership, served on a Safety Committee, and conducted internal audits Show less

Orange County, California, United States

● Tested protective and anti-inflammatory capabilities of compounds on RPE cells under oxidative stress and investigated the underlying mechanism of action on Age-related Macular Degeneration

Master'S Degree, Virology, 3.89

Activities and Societies: Member of AAAS: the American Association for the Advancement of Science. Member of Sigma Xi: The Scientific.

Education record

Mini MBA in Marketing

In The Ph.D. Program In Microbiology And Molecular Genetics

Bachelor Of Applied Science (B.A.Sc.), Biochemistry And Molecular Biology

Bachelor'S Degree, Molecular Genetics