I want to help

With over a decade of experience leading laboratory operations across molecular diagnostics, biorepository management, and biotech production, I offer consultation services designed to elevate your facility's performance, compliance posture, and scientific output. Whether you're building a new operation from scratch, preparing for a regulatory inspection, or looking to optimize existing workflows, there is a data-driven path forward.

I provide comprehensive consultation across laboratory operations, regulatory compliance, and molecular diagnostics, with a focus on quality systems, audit readiness, and scalable infrastructure design.

Laboratory Operations and Strategy

  • Facility design, equipment selection, and capital procurement planning

  • SOP development and revision aligned with CAP, CLIA, and OSHA standards

  • LIMS architecture, sample tracking, and data workflow design

  • Lean Six Sigma process optimization (DMAIC) for throughput and turnaround time

  • Multi-site operational standardization for centralized and satellite laboratories

  • Staffing structure design, competency matrix development, and training program buildout

Regulatory Compliance and Audit Readiness

  • CAP and CLIA inspection preparation and internal audit program design

  • Quality management program implementation with KPI monitoring and CAPA frameworks

  • EHS program coordination and safety compliance documentation

  • Chain of custody protocol design and validation

  • Corrective and preventive action system development

Biorepository and Specimen Management

  • Biorepository design, buildout, and accreditation preparation (CAP-BAP)

  • Specimen collection, processing, accessioning, and distribution workflow design

  • Cold storage infrastructure planning (LN2, negative 80, negative 20) with alarm and monitoring systems

  • Germplasm and biological asset management with genetic stability monitoring

  • Financial modeling for core facility pricing, billing, and cost recovery

Molecular Diagnostics and Assay Development

  • Assay development and validation (qPCR, RT-qPCR, endpoint PCR, NGS library prep)

  • Nucleic acid extraction, quantification, and quality control pipeline design

  • Test menu development and database management

  • Bioinformatics pipeline and automated data processing implementation (Python, SQL)

  • R&D to production tech transfer and scale-up

Laboratory work by Phillip Estrin