Molecular Diagnostics R&D Consultant

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Summary

This Molecular Diagnostics R&D Consultant is a Board-Certified High-Complexity Laboratory Director and fractional laboratory consultant with over 15 years of experience in molecular diagnostics and clinical laboratory leadership. He brings deep expertise in PCR (qPCR/ddPCR) and next-generation sequencing (NGS) technologies, with a strong focus on assay validation, analytical and clinical data review, and regulatory compliance in CLIA/CAP/COLA environments. 

This Molecular Diagnostics R&D Consultant has served as a Laboratory Director, Technical Supervisor, and scientific advisor across multiple clinical laboratories, where he has been responsible for reviewing and approving molecular data, validating new assays, and ensuring readiness for inspections and regulatory scrutiny. He is particularly effective at “pressure testing” data packages—evaluating study design, performance metrics, and supporting documentation to ensure results are accurate, defensible, and aligned with high-complexity laboratory standards. 

This Molecular Diagnostics R&D Consultants experience spans a range of molecular applications, including oncology-related assays, genetic testing, pharmacogenomics, infectious disease, where he has contributed to assay development, validation, and clinical implementation. He combines hands-on technical depth with practical laboratory leadership, making him well-suited for fractional R&D Lab Director roles requiring both strategic oversight and detailed execution. 

Highlights

• 15+ years in molecular diagnostics and clinical laboratory operations 

• Board-Certified High-Complexity Laboratory Director (ABB) 

• Deep expertise in CLIA / CAP / COLA compliance and inspection readiness 

• Extensive hands-on experience with qPCR, ddPCR, and NGS-based assays 

• Oncology-related, genetic, and pharmacologenomics testing 

• Assay validation, analytical performance evaluation, and data review 

• Proven ability to review and approve clinical data and identify validation gaps 

• SOP development, quality systems, and CAPA processes 

• Lab startups, inspections, and operational scale-up 

• Skilled in NGS bioinformatics analysis and variant interpretation (ACMG guidelines)

Relevant Accomplishments

• Currently provides fractional laboratory leadership and technical oversight, ensuring assay development, validation, and data review activities align with CLIA, CAP, and COLA standards 

• Led and supported validation of molecular diagnostic assays (qPCR, ddPCR, NGS) across multiple applications, ensuring analytical accuracy, reproducibility, and clinical reliability 

• Routinely performs in-depth analytical and clinical data reviews, formally approving molecular test results and ensuring data integrity—bringing a strong capability to “pressure test” data packages for completeness and defensibility 

• Designed and validated molecular diagnostic assays, including oncology-related panels, supporting clinical testing and laboratory service expansion 

• Evaluateed study design and validation approaches, identifying gaps in limit of detection, precision, and performance characterization, and recommending additional work needed for high-complexity lab compliance 

• Applied NGS bioinformatics pipelines and ACMG-based variant interpretation, ensuring accurate classification and clinically meaningful reporting of genetic findings 

• Led inspection readiness efforts and post-audit remediation, supporting successful outcomes across CLIA, CAP, and COLA surveys 

• Developed and maintained quality management systems, including SOPs, proficiency testing programs, competency assessments, and corrective/preventive actions (CAPA) 

• Conducted technical review and sign-out of molecular diagnostic results, ensuring compliance with regulatory standards and internal quality thresholds 

• Supported laboratory startup and expansion initiatives, including workflow design, staff training, assay implementation, and operational scaling in regulated environments 

• Provided consulting and technical support to clinical laboratories, assisting with assay troubleshooting, validation strategy, and regulatory alignment 
• Led and supported laboratory operations across molecular diagnostics, oncology research, and translational biology environments 

Roles

Fractional Laboratory Director / Technical Consultant, Multiple Organizations 
•    High-Complexity Laboratory Director, MDX Laboratory Solutions 
•    Chief Scientific Officer & CLIA/COLA Technical Supervisor, Equilibrium Scientific 
•    CLIA/CAP/COLA Technical Supervisor, Multiple Laboratories (Flexsus, Labgen, Raazi, Innovative Genomics) 
•   General Laboratory Manager / Technical Supervisor, Diaxlabs 
•   Group Leader & Senior Scientist (cGMP/GLP), Avance Biosciences 
•   Senior Scientist, Mayo Clinic

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