Director of Laboratory Operations

OncoHost is a technology-driven leader in precision medicine, advancing patient outcomes through innovative, clinically validated diagnostic solutions. The company’s proprietary PROphet® platform enables physicians to predict treatment efficacy, supporting more informed, data-driven immuno-oncology decisions. Role Overview The Director of Laboratory Operations will lead the company’s CLIA‑certified laboratory operations in Cary, North Carolina. This role is responsible for ensuring high‑quality, compliant, and efficient laboratory operations while aligning operational execution with the company’s scientific and clinical goals. Duties and Responsibilities Leadership & Team Management Directly manage and mentor the Laboratory General Supervisor, laboratory technologists andOffice Admin. Build, train, and develop a high‑performing laboratory team. Set clear goals, priorities, and performance expectations. Ensure effective communication and collaboration across laboratory, R&D, and cross‑functional teams. Laboratory Operations Oversee daily laboratory operations, including specimen processing, test performance, data analysis, and reporting. Ensure all laboratory activities are performed in accordance with approved procedures and regulatory requirements. Monitor workload, resource allocation, and turnaround times to ensure operational efficiency and scalability. Ensure proper documentation and maintenance of all laboratory records. Provide hands‑on support for benchwork as needed to maintain workflow continuity and turnaround times. Assist with sample accessioning and chain‑of‑custody documentation during peak volume periods or staffing gaps. Periodically perform hands‑on testing runs of the laboratory’s validated assay workflow to maintain technical familiarity, support troubleshooting, and ensure operational coverage. Quality & Compliance (CLIA / CAP) Ensure full compliance with CLIA regulations (42 CFR Part 493) and laboratory best practices, in close collaboration with the Laboratory Director. Oversee the implementation and ongoing adherence to quality control and quality assurance programs. Ensure accurate and complete documentation of: Quality control activities Instrument calibration and maintenance Equipment verification and validation Ensure proficiency testing is conducted, reviewed, and documented in accordance with regulatory requirements. Lead laboratory audits, inspections, and inspection‑readiness activities. Problem Solving & Continuous Improvement Identify operational, technical, or quality‑related issues that may impact test performance. Ensure proper investigation, documentation, and resolution of issues, including execution of CAPA processes. Drive continuous improvement initiatives across laboratory workflows. Work closely with leadership, R&D, Quality, Operations, Clinical, and Commercial teams. Support strategic initiatives, including expected product & indication launches and laboratory scaling activities. Contribute to scientific and operational planning. Qualifications Master’s or PhD in Life Sciences (Biology, Biochemistry, Molecular Biology, Immunology, or related field). Minimum of 5 years of experience in a clinical laboratory performing high‑complexity testing. Prior experience in a leadership or supervisory role (e.g., General Supervisor or equivalent). Strong knowledge of CLIA regulations and laboratory quality systems. Experience with automated high‑complexity assays. Familiarity with proteomics assays and microarray technologies (e.g., Agilent) is a plus. Strong leadership, organizational, and interpersonal skills. Detail‑oriented with strong problem‑solving capabilities. Ability to work independently with remote supervision. Highly motivated with a proactive, results‑driven mindset. Working Conditions This is an on‑site position requiring presence in the office five days per week, with flexibility as needed to support laboratory operations. #J-18808-Ljbffr Oncohost