Shorten validation-to-launch timelines
Coordinate LDT and clinical assay development through validation and readiness for routine use, while maintaining applicable controls.
Industries · Diagnostic testing & laboratory services
Diagnostic testing & laboratory services
Clinical testing, laboratory-developed tests, laboratory workflows, and analytical testing across U.S. and international environments.
Context
From strategy to execution in diagnostic testing
Diagnostic testing organizations must manage complex workflows, turnaround-time expectations, and applicable regulatory and quality requirements. I help clinical laboratories, LDT developers, and analytical testing groups improve execution, operational reliability, and service delivery.
My approach combines structured coordination with practical workflow improvement to align scientific and operational priorities and deliver measurable results.
Support
How I support diagnostic testing organizations
Build audit-ready lab operations
Integrate documentation, change control, and review practices into workflows to support applicable accreditation and assessment requirements.
Scale testing capacity without losing quality
Coordinate LIMS, instruments, and analytical workflows to increase testing capacity while protecting turnaround time and result integrity.
Environments
Laboratory & testing environments I serve
Clinical diagnostic laboratories
Clinical testing operations balancing turnaround-time targets with applicable quality and operational requirements.
Laboratory-developed test (LDT) developers
Teams coordinating LDT development and validation, with applicable CLIA requirements, CAP accreditation, and FDA oversight considerations in view.
Analytical & reference testing laboratories
Specialty and reference labs running high-complexity assays at scale for hospital, physician, and biopharma clients.
Precision medicine, oncology & genomics programs
Molecular diagnostics, pathology, and genomic testing programs translating science into clinically actionable results.
Deliverables
How I deliver
Integrated workflow & readiness plans
Establish an integrated readiness plan linking laboratory operations, quality activities, and applicable regulatory milestones.
Risk & assumption register
Identify and track assay-performance, supply, and capacity risks early enough to support mitigation and informed decisions.
Roles & decision rights
Define responsibilities and decision authority across laboratory operations, quality, and program leadership.
Performance dashboards
Monitor turnaround time, quality indicators, and capacity against defined operational targets.
Validation & compliance documentation
Integrate documentation into workflows to support applicable CAP accreditation, CLIA requirements, and ISO 15189 assessments.
Implementation roadmap
Sequence workflow improvements and implementation milestones to minimize disruption to ongoing testing operations.
Challenges
Challenges I help solve
Cross-functional execution gaps
Laboratory operations, scientific teams, and quality functions work to different timelines, delaying testing readiness and operational decisions.
Limited visibility & fragmented systems
Disconnected LIMS, instruments, and spreadsheets limit visibility into testing readiness, throughput, and capacity.
Slow or inconsistent LDT development cycles
Validation approaches vary across assays, creating inconsistent paths from feasibility to routine testing.
Scaling without compromising quality
Testing volume grows faster than the operational controls and capacity needed to maintain consistent quality.
The objective is scalable testing operations supported by consistent workflows, appropriate controls, and effective coordination.
Next step
Let’s discuss your needs
Have a program management challenge, a critical initiative, or an opportunity to improve execution? Get in touch to explore how I can help.