Dauer Enterprises, PBC is a Delaware C-Corp and Public Benefit Corporation committed to transforming healthcare by addressing unmet medical needs. Our initial mission is to develop a revolutionary assay to diagnose ALS using Oxford Nanopore’s epigenome sequencing technology.As a Public Benefit Corporation, we are guided by a dual mandate: to lower healthcare costs for patients—ensuring increased access to life-changing diagnostics across the globe—and to deliver sustainable value to our shareholders. By combining cutting-edge innovation with a patient-first approach, we aim to make high-quality diagnostics accessible and affordable worldwide, starting with ALS.

• Directed cross-functional team implementing LabVantage LIMS, achieving a 30% reduction in process deviations.• Developed User Requirements and led User Acceptance Testing (UAT), tracking progress in JIRA.• Led LIMS customization, including master data setup and API integration with systems like Hamilton automation, ensuring seamless data flow.• Configured sample classes for various assays, created custom forms, automated results parsing, and implemented business rules for data integrity and flagged results review.• Managed LIMS configuration tasks, breaking down complex workflows into sprints, and tracking them to resolution in JIRA.• Integrated LabVantage with NetSuite ERP for reagent tracking, COGS calculations, and efficient reordering.• Established a project prioritization framework, increasing project completion rates by 25%.Skills• Cross-Functional Team Leadership: Expert in guiding multidisciplinary teams through complex projects.• Strategic Planning & Operations Management: Align organizational objectives with long-term strategic goals.• Project & Program Management: Skilled in leading full lifecycle projects from planning through delivery.• Laboratory Information Management System (LIMS): Extensive experience in LabVantage LIMS customization and workflow optimization.• Good Clinical Practice (GCP): In-depth knowledge of GCP principles in clinical trials and regulatory environments.• Business Intelligence (BI): Proficient in Tableau for data analysis and decision support.• Financial Accounting & Budget Management: Competent in managing budgets, financial reporting, and cost analysis.Molecular Technologist & DNA Sequencing: Expertise in next-generation sequencing (NGS) and molecular diagnostics.

• Shepherded lab operations through the initiation of COVID pandemic lockdowns, ensuring continuous lab operations.• Managed a team of 45 employees, with 8 direct reports.• Scaled sample processing capacity through strategic automation and scheduling, doubling capacity from 9,000 to 22,000 samples per month.• Implemented COGS modeling and capacity planning, leading to a 15% cost reduction in unnecessary repeat testing.

• Enhanced compliance by updating and modernizing QC and manufacturing records, expertly adhering to ISO 13845 and cGMP standards.• Developed training framework to ensure staff were appropriately trained in SOPs and also up to date on CMEs.• Played a key role in regulatory submissions (FDA 510(k) and EUA), ensuring compliance and successful approval within project timelines.• Oversaw audits and certification by NYS-CLEP, CLIA, and CAP accreditation.

• Trained and supervised clinical staff in processing patient samples through next generation sequencing; independently performed data and flowcell QC.• Created and managed models for capital expenditures, re-order points for reagents, and staffing plans to ensure we met our projected sample goals.

Managed procurement, training, and implementation of two LIMS systems.Developed and validated SOPs for clinical sample processing.Established a CAP accredited clinical diagnostics laboratory.Specialized in automation engineering of high throughput sample processing.Oversaw day-to-day patient testing and cross-functional coordination.

Conducted clinical testing in molecular diagnostics.Established a relational database for ordering and tracking reagents.Managed development projects of novel assays for pathogen detection.Assisted in teaching molecular rotation for School of Medical Laboratory Science.

Managed clinical research activities and study budgets.Established an electronic study management software solution.Independently enrolled and managed patients in multiple Phase III clinical research trials.

Organized and coordinated undergraduate research projects on chromatic remodeling proteins

Statistical genetics