Fractional CLIA Laboratory Director

Job overview

The Fractional CLIA Laboratory Director role is hybrid in Washington, DC, with approximately one day per week onsite and remote availability as needed. Compensation is not specified. The role supports an innovative molecular diagnostics startup developing an investigational blood-based RNA assay using multiplex digital PCR and working toward FDA 510(k) clearance. The director provides scientific, technical, operational, and quality oversight during assay development and validation. The role supports reliable laboratory data, quality systems, personnel oversight, and regulatory readiness for the planned submission.

What you'll do

• Provide scientific, technical, and operational oversight of an investigational molecular diagnostics laboratory
• direct assay development, optimization, verification, and analytical validation
• oversee blood-based RNA biomarker testing and multiplex digital PCR workflows
• review and approve protocols and validation studies within assigned authority
• support FDA 510(k) efforts and regulatory documentation
• establish laboratory quality systems, SOPs, and controlled documentation
• support investigations, CAPA, audits, and quality improvement
• guide laboratory personnel and oversee qualifications, training, and competency
• oversee instrument qualification, calibration, maintenance, and quality control.

What we're looking for

Skills & competencies

fractional clia laboratory director

washington dc

hybrid

staff icons

molecular diagnostics

molecular pathology

rna biomarkers

digital pcr

fda 510(k)

laboratory quality systems

analytical validation

approximately one day per week onsite

Work arrangement

• Weekend coverage required

Why this role

Fractional consulting arrangement requiring approximately one onsite day per week. The posting requires a doctoral qualification and substantial molecular diagnostics, laboratory leadership, and analytical validation experience; applicable board certification is highly preferred.

About the employer

Staff Icons is hiring for this role. Industry: Medical Laboratories. Sector: 62.