Biorepository Operations Manager | Specimen Integrity Lead

BioSpace; Durham (NC); On-site; USD 100,000 - 133,000; Full time

Job summary

GRAIL is seeking a Manager, Biorepository Operations to lead on-site and off-site biorepository activities in Durham, NC. You will oversee specimen lifecycle management for roughly 1 million samples, manage vendors, and ensure regulatory compliance across CAP, CLIA, OSHA, HIPAA, and international standards.

The role requires extensive supervisory experience in a regulated biorepository setting, strong leadership, and hands-on involvement with inventory systems and storage operations.

Qualifications

• Bachelor’s degree in a science-related field required; advanced degree preferred.
• Typically requires 8+ years of relevant laboratory or biorepository experience, including 3–5 years in a supervisory or managerial role.
• Demonstrated experience managing large-scale biorepository operations and biological specimen inventories.
• Strong working knowledge of biorepository best practices, cold chain management, and chain-of-custody processes.
• Experience with CAP Biorepository Accreditation Program requirements and accreditation readiness activities preferred.
• Experience managing third-party storage vendors and international operations preferred.
• Experience with laboratory information management systems (LIMS) and/or standalone biorepository inventory software.

Responsibilities

• Oversee daily operations of the biorepository, including receipt, accessioning, processing, storage, retrieval, shipment, inventory reconciliation, and disposal.
• Manage inventory for approximately 1 million biological specimens across on-site and off-site storage locations.
• Lead relationships with domestic and international third-party storage vendors, ensuring service quality and compliance.
• Ensure accurate chain-of-custody documentation and specimen traceability.
• Develop biorepository staff in tracking, disposal, maintenance, and storage operations; include coaching and career development.
• Maintain and optimize biorepository inventory software and workflows for accurate specimen tracking.
• Ensure compliance with CAP, CLIA, OSHA, HIPAA, and ISO standards; support CAPA and continuous improvement.
• Lead CAP Biorepository Accreditation activities, including audits and corrective actions.
• Monitor storage capacity, environmental monitors, freezer performance, and contingency plans.
• Collaborate with Facilities, Quality, Clinical Ops, Research, IT, and vendors to support infrastructure and logistics.
• Analyze operational metrics to improve efficiency and accuracy.
• Support budget planning and resource allocation.
• Participate in hands-on specimen handling and storage operations as needed.
• Foster a collaborative, safety-driven, and quality-focused work environment.

Skills

Biorepository operations

LIMS

Inventory management

Vendor management

Regulatory compliance

CAP/CLIA standards

Education

Bachelor’s degree in science

Master’s degree preferred

Tools

LIMS software

Biorepository software

Job description

GRAIL is seeking a Manager, Biorepository Operations to lead on-site and off-site biorepository activities in Durham, NC. You will oversee specimen lifecycle management for roughly 1 million samples, manage vendors, and ensure regulatory compliance across CAP, CLIA, OSHA, HIPAA, and international standards.

The role requires extensive supervisory experience in a regulated biorepository setting, strong leadership, and hands-on involvement with inventory systems and storage operations.