Manager Biosample Operations # 4899

Grail•Durham, NC

11d•Onsite

About The Position

GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges. GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. 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.

Requirements

Bachelor’s degree in a science-related field required; advanced degree (Master’s) preferred.
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.
Demonstrated experience with CAP Biorepository Accreditation Program requirements and accreditation readiness activities strongly preferred.
Experience managing third-party storage vendors and external logistics providers, including international operations preferred.
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.
Minimal applicable standards for this position include: CAP Biorepository Accreditation Program, 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).

Nice To Haves

Proven leadership and team management capabilities in a regulated laboratory or biorepository environment.
Strong operational planning and organizational skills with the ability to manage complex specimen inventories across multiple locations.
Excellent communication and interpersonal skills for working with staff, leadership, vendors, and cross-functional stakeholders.
Strong attention to detail and commitment to specimen integrity, data accuracy, and compliance.
Ability to analyze operational data, identify trends, and implement process improvements.
Solid problem-solving and decision-making skills in a highly regulated environment.
Experience managing budgets, vendor relationships, and operational resources.
Ability to work effectively in both strategic and hands-on operational capacities.

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.