<p>CLIA Lab Director | Molecular Diagnostics</p> <p>Proven clinical laboratory leader with extensive experience operating CLIA-certified, high-throughput molecular testing laboratory. Strong comfort level working alongside R&D and regulated product development. Demonstrated success in workflow optimization, throughput scale-up, capacity planning, space optimization to drive operational efficiency and quality. Track record showing the ability to handle tight deadlines and quick turnarounds, the flexibility for dynamic and evolving workflows, the capability to identify the root cause and create viable solutions. A true leader to lead and manage a dynamic team to deliver high-quality clinical results for patients.</p> <p>Core Competencies</p> <ul> <li>CLIA Lab Setup, Expansion, and Compliance </li><li>Molecular Diagnostics (PCR, qPCR, NGS) </li><li>High-Throughput Laboratory Operations </li><li>Laboratory Automation & Scalability </li><li>Capacity Planning & Throughput Optimization </li><li>Regulatory Compliance (CLIA, CAP, ISO, FDA) </li><li>Cross-Functional Leadership and communication </li><li>Quality Systems & Risk Management </li></ul> <p>Who we are:</p> <p>Insight Molecular Diagnostics, Inc (iMDx) is dedicated to advancing precision medicine in transplantation and oncology. At iMDx, we believe that everyone deserves access to the best possible healthcare. We envision a world where critical molecular diagnostic tests are accessible to all.</p> <p>Our mission is to democratize access to cutting-edge diagnostic solutions by making precision medicine more widely available through both clinical testing and research-driven collaborations. By empowering physicians, researchers, and patients with clear, actionable insights, we help drive informed decision-making and better health outcomes.</p> <p>Professional Experience</p> <ul> <li>Led and expanded a CLIA-certified diagnostics laboratory and achieved CLIA certification for additional product lines under tight timelines. (Molecular experience preferred) </li><li>Scaled operations up to 300+ samples/day, maintained quality standards, turnaround time, and regulatory compliance. </li><li>Oversaw all aspects of daily lab operations including personnel management, proficiency testing, training, safety, lab readiness, and continuing improvement of the quality. </li><li>Comfortable with rapid growth and eager to partner with R&D and Product Development for revenue-supporting implementations. </li><li>Experience in workflow automation and lean lab practices to improve efficiency, reduce error rates, and support scale-up. </li><li>Conducted capacity planning and modeling to guide equipment investment, staffing, budget planning, and offering expertise from a CLIA-lens toward long-term growth strategy. </li><li>Participated in assay development, optimization, verification, and validation, supporting both LDT and FDA regulatory pathways in collaboration with R&D and Product Development teams. </li><li>Served as the technical expert for laboratory staff, overseeing test execution, data review, troubleshooting, and corrective action processes. </li><li>Ensured continuous audit readiness and maintained documentation and compliance with all state, federal, and CLIA regulatory bodies. </li><li>Worked closely with the Medical Laboratory Director and Quality team to align processes with state/federal regulations and company policies. </li><li>Led laboratory quality assurance and compliance efforts, including periodic internal reviews, SOP optimization, and metrics-driven performance management. </li><li>Recruited, trained, and managed lab personnel; responsibilities included interviewing, onboarding, performance evaluation, coaching, and corrective actions. </li><li>Maintained and monitored lab instrumentation, ensuring timely calibration, maintenance, and documentation. </li><li>Promoted a culture of safety and accountability, ensuring adherence to safety protocols and maintaining a clean, organized lab environment. </li><li>Supported the development of lab KPIs and service-level goals to drive operational excellence and high-quality clinical outputs. </li></ul> <p>What you bring to the table:</p> <ul> <li>Current Tennessee Clinical Laboratory Scientist (Generalist) or Clinical Genetic Molecular Biologist Scientist (CGMBS) License </li><li>State of TN Supervisor License </li><li>Bachelor's Degree (minimum) in Life Sciences (Biological Sciences background), PhD preferred. </li><li>Agile and flexible adapting to a rapidly changing field, including changes in regulatory requirements and customer needs </li><li>Six Sigma Green Belt / Lean Six Sigma Certified is a plus </li><li>5S Workplace Organization preferred </li><li>Refer to CFR Title 42 § 493.1489 for additional qualification criteria. </li><li>5+ years of clinical laboratory experience in a supervisory role in a high-volume clinical laboratory. </li><li>ASCP Certification or equivalent </li><li>Technical experience in Molecular Diagnostics, is required. </li><li>Experience implementing and managing CLIA QMS. </li><li>Experience with preparing for and coordinating laboratory inspections by Federal, State, and other governing agencies. </li><li>Must have excellent interpersonal skills, demonstrated ability to work effectively with multiple disciplines, good team approach, good written and oral communication skills, administrative skills </li><li>Highly organized, good documentation skills and attention to details are essential. Results and goals oriented, having integrity, a strong work ethic and a commitment to quality </li><li>Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities. </li></ul> <p>Physical Demands:</p> <ul> <li>Standing, sitting, walking, bending, reaching, manual manipulation, and lifting 25 pounds. </li><li>Ability to have full-body movement </li><li>All candidates must take a color vision test. </li><li>Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for at least 50% of a typical working day. </li><li>Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height. </li></ul>