Jobs in Durham, NC

About the role

The Manager, Biorepository Operations provides leadership and oversight for the organization’s on-site and off-site biorepository operations, ensuring operational excellence, regulatory compliance, and alignment with organizational goals. This role is responsible for the management, tracking, maintenance, storage, retrieval, and disposal of biological specimens across a large-scale repository environment supporting approximately 1 million samples in storage. The Manager oversees day-to-day biorepository activities, including management of domestic and international third-party storage vendors, maintenance of standalone biorepository software systems, and leadership of the operational team responsible for specimen lifecycle management. This individual serves as a subject matter expert in biorepository best practices and ensures compliance with applicable regulatory, quality, and accreditation standards, including the CAP Biorepository Accreditation Program. This is a hands-on, on-site leadership role requiring active participation in operational workflows and direct engagement with specimen management activities.

What you'll bring

• CAP Biorepository Accreditation Program
• Bachelor’s degree in a science-related field required
• Typically requires 8 + years of relevant laboratory or biorepository experience, including 3–5 years in a supervisory or management role.
• Demonstrated experience managing large-scale biorepository operations and biological specimen inventories.
• Strong working knowledge of biorepository best practices, cold chain management, specimen lifecycle management, and chain-of-custody processes.
• Experience managing third-party storage vendors and external logistics providers
• Experience with laboratory information management systems (LIMS) and/or standalone biorepository inventory management software required.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance.
• Clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189)
• Biorepository and biospecimen management best practices (e.g., ISBER guidelines)
• Operations within regulated medical device and clinical study environments (e.g., FDA 21 CFR Part 11, ICH E6/GCP, ISO 20916)
• Demonstrated experience with CAP Biorepository Accreditation Program requirements and accreditation readiness activities strongly preferred.

Benefits