Biotech Program Leader

Zachary Yanagihara

I help modern biotech teams turn complex scientific and operational challenges into scalable diagnostic products, laboratory systems, and clinical-ready workflows.

Zachary Yanagihara headshot

I am motivated by the work required to turn ambitious science into systems that can operate in the real world.

My interest is in helping biotech teams move meaningful programs forward with both rigor and momentum. The problems that have drawn me throughout my career sit at the intersection of science, operations, quality, and execution—where success depends not only on good ideas, but on building the systems, processes, and cross-functional alignment required to make those ideas real.

I studied biomedical engineering at Cal Poly San Luis Obispo, which gave me an early foundation in applying engineering discipline to complex medical and biological problems. That training has shaped the way I work: I tend to approach programs by breaking down ambiguity, aligning stakeholders, and building practical paths from concept to implementation.

Professionally, I have worked across diagnostics, medical devices, and laboratory operations at PrognomiQ, GRAIL, Abbott, and Applied Medical. My experience has included leading development of a novel early-stage lung cancer LDT from ideation through validation and first commercial testing in a CLIA environment, directing cross-functional work to achieve CLIA and CAP accreditation readiness, deploying a customized LIMS to support the end-to-end LDT workflow, orchestrating a 2,513-subject multi-omics observational study, supporting scale-up of a commercial laboratory designed for more than 1 million patient samples annually, reducing annual kit costs by $850K, and driving process improvements that reduced final QA inspection failures by 75 percent. I am most energized by work that requires structured execution, strong collaboration, and a willingness to solve hard problems well.

Selected outcomes across diagnostics, laboratory systems, and product execution.

Early-stage lung cancer LDT development

Directed full lifecycle development of a novel early-stage lung cancer laboratory developed test, leading multidisciplinary work from product ideation and assay design through validation and first commercial testing in a CLIA environment.

CLIA/CAP commercial laboratory readiness

Led cross-functional efforts to achieve CLIA and CAP accreditation readiness, implementing validated quality systems and operational processes required to support commercial diagnostic operations.

Laboratory systems and workflow infrastructure

Built operational infrastructure for a mass spectrometry and automation laboratory and led deployment of a customized LIMS platform supporting sample accessioning, assay data ingestion, machine learning workflow execution, and clinical results reporting.

Large-scale multi-omics study execution

Orchestrated planning and execution of a 2,513-subject multi-omics observational study, coordinating laboratory operations, data generation, and publication support across a large cross-functional program.

Commercial lab scale-up at GRAIL

Supported launch readiness for Galleri and led system integration efforts for a high-throughput commercial laboratory designed to process more than 1 million patient samples annually.

Process and cost improvements

Delivered measurable operational improvements across multiple organizations, including $850K in annual kit cost reduction at GRAIL, 75 percent fewer final QA inspection failures at Abbott, and 60 percent material cost reduction at Applied Medical.

The kinds of work I have consistently led.

Product launches and readiness

Supported commercialization of diagnostic products by translating technical development work into validated, operationally ready laboratory processes and systems.

Laboratory scale-up

Helped build and integrate the workflows, automation, and data systems needed to scale complex diagnostic laboratories from development into production-ready operations.

Cross-functional program leadership

Led execution across scientific, engineering, operations, quality, regulatory, and external partner teams to move high-stakes programs forward with clarity and accountability.

Regulated execution

Worked across FDA, CLIA, and CAP-regulated environments, with hands-on experience in validation strategy, design controls, quality systems, and operational readiness.

Operational improvement

Repeatedly improved cost, quality, and throughput through structured process development, system implementation, and disciplined program management.

Mission-driven collaboration

I am especially interested in working with teams that care deeply about building useful products, solving difficult problems, and creating real value in healthcare and biotechnology.

Let’s connect.

If you are building in diagnostics, laboratory systems, biotech operations, or adjacent areas where complex programs need strong execution, I would be glad to connect.