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Contract CLIA Laboratory Director & Consultant

October '25 | Birmingham, AL | Remote with Occasional In-Person Visits

Description

Celestia Diagnostics translates cutting-edge research in long COVID and other complex, chronic conditions into clinically validated diagnostic tests. We seek an experienced Contract Laboratory Director & Laboratory Consultant to provide regulatory oversight and clinical leadership while working closely with our R&D team.

Responsibilities

  • Ensure compliance with CLIA and applicable federal/state regulations (e.g., HIPAA, biosafety)

  • Review and approve the Quality Management System (plans, SOPs, policies, and QA records)

  • Review/approve validation or verification of new or modified LDTs and their analytical performance
    Oversee proficiency testing (PT) or conduct alternative assessments where PT is unavailable

  • Oversee staff competency training and assessment

  • Maintain inspection readiness and conduct mock audits

  • Advise clinicians on test selection and interpretation

Qualifications & Other Requirements

  • Meets CLIA Laboratory Director requirements:

    • Option 1: MD/DO licensed and board-certified in anatomic or clinical pathology (preferred), or

    • Option 2: PHD in biology, laboratory science, or a related field and HHS-approved board certification (e.g., ABB, ABMM, ABCC, ABMGG)

  • Minimum 3 years directing or supervising high-complexity testing

  • Strong knowledge of quality management fundamentals and their application to blood-based quantitative assays

  • Excellent written and verbal communication

  • Preferred: Based in the Southeastern US

Engagement details

  • Competitive hourly rate, commensurate with experience, with travel expenses reimbursed

  • Preferred start date in November of 2025

  • Contract role with flexible hours, typically 1–5 per week, primarily remote with additional availability for in-person visits

Why join

  • Translate cutting-edge assays for long COVID that have real-world impact, and the potential to set new standards of care

  • Collaborative culture that values transparency, speed, and quality

  • Opportunity to contribute to scientific publications and presentations

How to Apply

Email your CV to careers@celestiadiagnostics.com.

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