CLIA Lab Director, Molecular Diagnostics

About Pathnostics

Pathnostics is a diagnostic solutions company offering transformative solutions that help clinicians resolve diagnostic and therapeutic dilemmas the first time. Our flagship test, Guidance UTI, combines molecular detection with a proprietary pooled antibiotic susceptibility test (P-AST) method that evaluates how antibiotics perform against the infection as a whole, providing a personalized result in 24-36 hours.

Role Summary

We are seeking a part-time Laboratory Director to oversee high-complexity molecular testing in our CLIA/NYS certified laboratory in Lake Mary, Florida. The Laboratory Director will oversee all testing activities in the laboratory, as per the CLSI 12 Quality System Essentials (QSEs), including but not limited to: review and oversight of the laboratory Quality Management System, monitoring test performance and collaborating with Quality personnel to investigate non-conformances, overseeing personnel competency, proficiency testing, and providing recommendations for improvement while maintaining compliance with CLIA, NYS, and Florida state requirements. This role will provide clinical guidance in operational leadership that will elevate quality and ensure patient safety while scaling a high-performing lab.

Location: the Lab Director will be available for consultation by laboratory personnel on a regular basis from his or her home office and maintain a schedule of at least 8 onsite work hours monthly at our Lake Mary lab site (onsite supervision is a NYS requirement). Candidates must be located in Florida State to be considered.

Additional duties and responsibilities:

• Ensures test systems produce quality results at all phases of the testing process
• Addresses any non-conforming work, ensuring remedial actions are taken and corrective actions plans are effective
• Ensures all laboratory personnel meet the education and experience requirements to perform their respective duties and competency is maintained and evaluated regularly
• Collaborates with laboratory and scientific personnel to review and approve validation documentation, quality assurance initiatives and documentation, and review/develop/maintain standard operating procedures (SOPs)
• Collaborates with operations leadership to ensure the facility and equipment support safe and reliable laboratory testing
• May perform the duties of a clinical consultant, technical supervisor, general supervisor (or delegate these responsibilities to qualified clinical laboratory personnel)
• Must be available for telephone and/or in-person consultation as needed by laboratory personnel and clients

Qualification Requirements:

• Must meet qualifications for Laboratory Director as specified in 42 CFR 493.1443 / 10 NYCRR SS 58-6.3
• A board-certified MD or DO who currently holds or qualifies to obtain the new 2026 requirements for NYS Certificate of Qualification for Laboratory Director (LDCQ). OR
• Holds a doctoral degree in a chemical, biological, or medical laboratory science, Microbiology or Molecular Biology preferred, with HHS approved board certification and 2+ years of experience supervising high-complexity testing and qualifies for the new 2026 NYS requirements for as Technical Director in the specialty of Microbiology (bacteriology, mycology, virology, and parasitology) (TDCQ).
• Must possess a current FL State medical license

Preferred Experience:

• Has worked closely with laboratory teams to validate and modify laboratory developed tests (LDTs) in reference laboratory environments
• 5+ years of experience leading teams through CAP and