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.

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)

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.

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.