CLIA / CAP Laboratory Expert Consultant

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Susan is an experienced molecular biologist / Clinical Services Director with 20+ years in cancer biology research, molecular biology and next generation sequencing services, and clinical genetic testing. He has 4-year experience building and directing a molecular testing laboratory using new tests including cystic fibrosis, True Sight cancer, a custom cancer panel, pharmacogenomics panel, urine tract infection, Covid19 test and sequencing. He is experienced with CLIA / CAP/NY state regulations, laboratory operations and management, assay development and validation and is well versed in Quality Assurance program development and practice. He has more than 4 years of clinical genetic testing lab operations experience including costing, labor forecasting, hiring, staffing, workflow planning and business plan development for laboratory rollout plans.

• 20+ years in molecular biology assays
• Private Corporation experience
• Expert in CLIA / CAP /NY State Regulations
• Clinical Laboratory expertise: Molecular diagnostics (infectious disease testing), next generation sequencing and genetic testing technologies
• Business / Lab Management & Planning Experience
• Qualified to direct high complexity medical diagnostic laboratories in Pennsylvania
• New Laboratory Services Rollout experience
• Molecular Diagnostics; Molecular Biology
• Assay Development
• Infectious Diseases

Relevant Accomplishments

  • Established a new genetic testing lab, from the ground up through CLIA and CAP accreditation.
  • Optimized, validated, and launched novel Laboratory Developed Tests.
  • Developed quality assessment programs to ensure comprehensive testing performance and detect issues in a timely manner and develop effective corrective action plans when necessary.
  • Responsible for overall operation and administration of a CLIA laboratory, ensuring that all duties were properly performed and applicable to CLIA regulations; Hired and maintained qualified personnel; Developed an effective quality system approach to laboratory testing that provided high accuracy and reliable patient test results.
  • Developed and implemented the clinical, technical and quality programs of a diagnostic testing laboratory for corporation in a manner consistent with the needs of clinicians and goals of the corporation. Oversaw validation and launch of new Laboratory Developed Tests and ensured that all activities were in full compliance with all regulatory requirements.
  • Acted as subject matter expert for next generation sequencing and high throughput real-time PCR testing, focusing on cancer germline mutation detection and pharmacogenomics clinical testing.


    • GLP study director
    • CLIA/CAP Laboratory NGS Director
    • GCLP study directo
    • Genomic Scientist of Molecular Pathology


    • Ph.D. in Biomedical Science
    • Post-doctoral training, Institute for Cancer Genetics

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