Senior Biorepository Operations Lead

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 100,000 - 133,000; Full time

Job summary

GRAIL is hiring a Manager, Biorepository Operations to lead on-site and off-site biorepository activities in a high-capacity environment supporting approximately 1 million samples. This hands-on role ensures regulatory compliance, quality standards, and efficient specimen lifecycle management across domestic and international vendors.

The position requires strong leadership, deep knowledge of CAP/CLIA regulations, and experience managing biorepository software systems, with on-site work at our

Responsibilities

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

Job description

GRAIL is hiring a Manager, Biorepository Operations to lead on-site and off-site biorepository activities in a high-capacity environment supporting approximately 1 million samples. This hands-on role ensures regulatory compliance, quality standards, and efficient specimen lifecycle management across domestic and international vendors.

The position requires strong leadership, deep knowledge of CAP/CLIA regulations, and experience managing biorepository software systems, with on-site work at our