Manager Biosample Operations # 4899

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.