Lisa Ford

Consultant | Director of Highly Complex Labs

  • Credentials:
  • Experience:
    Board certified high-complexity clinical laboratory director (American Board of Bioanalysis) with New York State Certificate of Qualification in multiple disciplines. Qualified and certified to direct in all states. Lisa has a proven record of leadership, technical expertise, laboratory and project management covering clinical testing, bioanalysis, and product development. Lisa is a strategic thinker focused on process improvement, KPIs, and quality indicators as well as an expert in regulatory compliance related CAP/CLIA, GCLP, GCP, GMP. 12+ years experience managing and directing a CAP / CLIA / GCP / ISO 9001 compliant clinical and bioanalytical laboratory, and associated quality systems in which novel multianalyte biomarker laboratory-developed tests are developed, validated, and performed using biochemical, immunoassay, and chromatographic techniques. Experience managing clinical assay development, transfer and validation, strategic planning and implementation, and lifecycle management including continual process efficiency and quality improvement, development and tracking of KPIs, financial aspects of the laboratory including pricing and budget development, vendor management, as well as laboratory personnel. Ensured regulatory compliance with oversight and management of the quality management system, preparing and reviewed regulatory submission documents, authoring internal and external publications and patents, and representing the company in audits by clients and regulatory agencies.
  • States: