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:

• 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.

Required Qualifications:

• 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)

Preferred Qualifications:

• 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.

Physical Demands and Work Environment:

• Work performed in a laboratory and biorepository environment with routine exposure to biological samples and cold storage conditions.
• Requires extended periods of standing, walking, freezer access, and occasional lifting up to 40 lbs.
• PPE (gloves, lab coats, safety glasses, and appropriate cold-weather protective equipment) required in designated areas.
• This is an on-site role requiring routine hands-on participation in specimen management operations.
• May require flexible work hours and availability during evenings, weekends, holidays, or emergency situations to support critical specimen storage operations and business continuity.

The expected, full-time, annual base pay scale for this position is $100K - $133K. Actual base pay will consider skills, experience, and location.

This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate's qualifications. Employees in this role are also eligible for GRAIL's comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.