Breast Oncology Translational Research Biorepository Manager will oversee the management of the DF/HCC Breast Program's translational research biorepository in its support of collecting, processing, storing, cataloging, and providing biospecimens for clinical trials, cohort studies, and translational research. Leads the development and maintenance of the wet lab infrastructure, supervises research technicians and clinical research coordinators in accordance with the research experimental policies and procedures for the clinical trials, cohort studies and specific translational research studies. Ultimately responsible for the day-to-day lab operations of the biorepository in that they adhere to safety guidelines and meet the objectives and standard operating procedures of all of the research studies and clinical trials. Act as the main point of contact for Principal Investigators and their study teams in the planning and execution of biospecimen collection for new study startups and design of transitional studies. Oversees specimen entry into the biorepository, collating and sharing specimens under appropriate IRB approvals, and working directly with the Co-Chairs of the DF/HCC Breast Clinical Data and Biospecimens Users Committee to oversee and manage, review, and execute biospecimen requests.

Primary Duties and Responsibilities:

• Lead biorepository operations and chain-of-custody: Direct end-to-end specimen operations including receipt, accessioning, storage, retrieval, and secure transport between locations; ensure accurate labeling, documentation, and chain-of-custody practices aligned to protocol requirements, institutional standards, and applicable regulatory expectations.
• Own inventory integrity and system-of-record performance: Manage specimen inventory control and reconciliation processes; ensure physical inventory aligns with electronic records; establish routine data-quality checks and corrective actions to maintain reliable, audit-ready documentation.
• Administer biorepository informatics (OpenSpecimen) and access workflows: Build and maintain study/protocol configuration (e.g., protocol setup, label design/testing, user access), partner with study teams on study start-up and amendments, and coordinate with internal technology resources to optimize functionality and reporting.
• Oversee billing, budgeting, and recharge operations: Manage iLabs account setup and service workflows, develop/track quotes and purchase orders as applicable, consolidate and reconcile monthly charges, and coordinate submission of billing charges/journal entries with Research Administration; monitor operational expenses and implement mitigation actions as needed.
• Manage freezer farm and critical equipment readiness: Oversee freezers and supporting laboratory equipment across sites, including maintenance/service coordination, calibration/maintenance documentation, relocations, sensor installation and monitoring coordination (e.g., with CAMS), review of temperature trends, and defined escalation/response processes for critical alarms, including after-hours coverage as needed.
• Drive SOPs, quality systems, and audit readiness: Develop, maintain, and implement SOPs and work practices; ensure staff training and adherence; maintain required records (e.g., temperature charts, calibration logs, inventory reports) and coordinate sponsor/customer audits and follow-up actions.
• Provide people leadership and workforce planning: Assess staffing needs and recommend resourcing; recruit, schedule, train, and develop staff across locations; set clear expectations, provide feedback, ensure cross-training/coverage, and foster a culture of safety, service, inclusion, and continuous improvement.

Knowledge, Skills and Abilities:

• Working knowledge of biorepository or clinical research specimen operations, including accessioning, labeling, storage/retrieval workflows, chain-of-custody practices, and documentation controls.
• Knowledge of safe handling practices for human specimens and cold-chain materials (e.g., dry ice, liquid nitrogen), including appropriate PPE and safe work practices.
• Proficiency with specimen inventory platforms and related workflows (e.g., OpenSpecimen), including study/protocol builds, label configuration/testing, user access coordination, reconciliation, and basic reporting.
• Proficiency with research service center billing/chargeback processes and tools (e.g., iLabs), including account setup, charge reconciliation, responding to billing inquiries, and coordination of journal entries with finance partners.
• Ability to maintain audit-ready records and support internal/external audits through strong documentation discipline, data integrity practices, and timely issue resolution.
• Strong operational and project management skills, including the ability to prioritize competing demands across multiple sites, manage timelines, and deliver reliable service levels.
• Demonstrated people-management skills, including hiring, onboarding, training, scheduling, performance coaching, competency/cross-training, and building an inclusive and accountable team culture.
• Strong problem-solving and decision-making skills, including ability to assess risk, escalate appropriately, and implement corrective/preventive actions.
• Strong written and verbal communication skills, including the ability to translate protocol/lab manual requirements into clear operational instructions and collaborate effectively with investigators, study teams, and sponsors/customers.
• Strong attention to detail, accuracy, and confidentiality when working with sensitive research information, study identifiers, and operational records.
• Proficiency with common productivity tools (e.g., Excel, Word, PowerPoint) and comfort working with shared file structures and institutional applications; ability to learn new systems quickly.
• Ability to manage vendor/service relationships for equipment maintenance and supplies, as applicable, and maintain continuity of operations through planned maintenance and contingency coverage.

Minimum Job Qualifications:

• Bachelor's degree required, preferably in the field of biological sciences, laboratory science, clinical research, health sciences, healthcare administration, or related field (laboratory management or clinical research). Master's degree preferred.
• A minimum of 5 years of experience in a healthcare laboratory, biorepository, or clinical research environment, including regulated/quality-focused specimen handling, storage, and tracking.
• Prior supervisory/lead experience required.
• Experience with biobanking inventory systems (e.g., OpenSpecimen) and research billing/chargeback platforms (e.g., iLabs) preferred.

Supervisory Responsibility:

• Supervisory responsibilities include the department's administrative team and Biorepository Core technical staff, expected to be at least 2 full-time equivalent staff members (up to 6).

Special Working Conditions:

• 100% Onsite.
• Ability to work with liquid nitrogen and dry ice.