Contract Laboratory Director & Consultant

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 • Contract role with flexible hours, typically 1–5 per week, primarily remote with additional availability for occasional in-person visits • Competitive hourly rate, commensurate with experience, with travel expenses reimbursed • Preferred start date in November of 2025 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 or directly through LinkedIn. Apply tot his job Apply To this Job