Manager Biosample Operations # 4899
GRAILAbout 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.
This role works on-site full-time at our office located in Durham, NC
Responsibilities:
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Oversee daily operations of the biorepository, including specimen receipt, accessioning, processing, storage, retrieval, shipment, inventory reconciliation, and disposal activities.
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Manage and maintain inventory for approximately 1 million biological specimens across on-site and off-site storage locations.
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Oversee relationships and operational activities with domestic and international third-party storage vendors, ensuring service quality, compliance, and inventory integrity.
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Ensure accurate chain-of-custody documentation, specimen traceability, and adherence to established specimen handling procedures.
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Lead and develop biorepository staff responsible for specimen tracking, picking, disposal, maintenance, and storage operations, including performance management, coaching, mentoring, and career development.
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Maintain and optimize standalone biorepository inventory management software and associated workflows to ensure accurate and efficient specimen tracking.
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Ensure compliance with all applicable regulatory, accreditation, quality, and safety standards, including CAP Biorepository Accreditation Program requirements, CLIA, CAP, OSHA, HIPAA, and applicable international standards.
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Develop, implement, and maintain biorepository SOPs, policies, workflows, and best practices to support operational consistency, quality, and regulatory compliance.
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Lead CAP Biorepository Accreditation activities, including audit preparation, inspections, corrective and preventive actions (CAPA), and continuous improvement initiatives.
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Monitor storage capacity, environmental monitoring systems, freezer performance, and contingency planning to ensure specimen integrity and business continuity.
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Partner with Facilities, Quality, Clinical Operations, Research, IT, and external vendors to support biorepository infrastructure, specimen logistics, and organizational priorities.
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Analyze operational metrics and inventory trends to improve efficiency, accuracy, utilization, and overall repository performance.
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Support budget planning, forecasting, equipment management, and resource allocation for biorepository operations.
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Participate directly in operational activities as needed, including specimen handling, freezer organization, inventory audits, and troubleshooting of storage systems and equipment.
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Foster a collaborative, safety-focused, and quality-driven work
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