Senior Biotech Program Leader
Building regulated diagnostics, scalable lab systems, and AI-enabled biotech operations.
I help modern biotech teams move faster by translating complex science, engineering, and regulatory requirements into executable programs, scalable workflows, and commercial-ready systems.
About
I am interested in helping modern biotech teams move faster—without sacrificing the rigor required to build products in regulated environments. My career has given me a front-row seat to where time, complexity, and coordination challenges accumulate across the lifecycle of diagnostics and medical technologies: from product concept and assay development through validation, laboratory operations, and commercialization.
I am a senior program and operations leader with a background in biomedical engineering and experience across early cancer diagnostics, medical devices, and laboratory scale-up. My work has included LDT development, cross-functional program leadership, validation strategy, LIMS implementation, and operational readiness in regulated environments.
Across roles at PrognomiQ, GRAIL, Abbott, and Applied Medical, I have worked at the intersection of science, engineering, quality systems, and operations to help teams translate complex technical work into scalable products and workflows. More recently, I have become particularly interested in how AI can reduce operational drag and improve how biotech organizations build, document, and deploy complex systems.
Track Record
Led full lifecycle development of a novel early-stage lung cancer LDT, directed CLIA/CAP readiness efforts, deployed a customized LIMS supporting the end-to-end diagnostic workflow, and helped operationalize large-scale multi-omics and laboratory programs.
Supported commercial launch readiness for Galleri, managed cross-functional programs tied to laboratory scale-up, led system integration for a high-throughput laboratory designed for more than 1 million patient samples annually, and executed V&V work supporting PMA submission requirements.
Led cross-functional manufacturing and process improvement work supporting HeartMate 3 LVAD production, driving design and process changes that reduced final QA inspection failures by 75 percent and improved production reliability.
Designed device components and associated development and validation processes for laparoscopic products, and led engineering cost-reduction work that reduced material costs by 60 percent while maintaining performance and regulatory standards.
Where I Create Impact
LDT development, validation strategy, regulatory execution, CLIA/CAP readiness, and commercialization support.
LIMS deployment, workflow automation, laboratory operations, and infrastructure for high-throughput diagnostic programs.
Driving alignment across R&D, operations, quality, regulatory, software, and external partners in complex environments.
Focused on how AI can improve scientific operations, documentation workflows, data systems, and product development velocity.
Experience bridging concept, design, validation, and manufacturing in both diagnostics and medical devices.
Contact
Whether you are building a diagnostic platform, scaling biotech operations, or exploring AI-enabled infrastructure for regulated environments, I am always interested in thoughtful conversations.