
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
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Ensure compliance with CLIA and applicable federal/state regulations (e.g., HIPAA, biosafety)
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Review and approve the Quality Management System (plans, SOPs, policies, and QA records)
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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
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Maintain inspection readiness and conduct mock audits
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Advise clinicians on test selection and interpretation
Qualifications & Other Requirements
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Meets CLIA Laboratory Director requirements:
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Option 1: MD/DO licensed and board-certified in anatomic or clinical pathology (preferred), or
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Option 2: PHD in biology, laboratory science, or a related field and HHS-approved board certification (e.g., ABB, ABMM, ABCC, ABMGG)
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Minimum 3 years directing or supervising high-complexity testing
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Strong knowledge of quality management fundamentals and their application to blood-based quantitative assays
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Excellent written and verbal communication
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Preferred: Based in the Southeastern US
Engagement details
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Competitive hourly rate, commensurate with experience, with travel expenses reimbursed
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Preferred start date in November of 2025
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Contract role with flexible hours, typically 1–5 per week, primarily remote with additional availability for in-person visits
Why join
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Translate cutting-edge assays for long COVID that have real-world impact, and the potential to set new standards of care
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Collaborative culture that values transparency, speed, and quality
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Opportunity to contribute to scientific publications and presentations
How to Apply
Email your CV to careers@celestiadiagnostics.com.