Director, Biorepository Core

Virginia Commonwealth University School of Medicine; Richmond (VA); On-site; USD 180,000 - 240,000; Full time

Job summary

Virginia Commonwealth University School of Medicine is seeking a Director of the Biorepository Core within the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health (SSLI) to provide strategic, scientific, and operational leadership for the biobanking and biospecimen processing enterprise.

The role oversees biospecimen acquisition, processing, storage, quality management, and regulatory compliance, and manages personnel and projects.

Qualifications

• Oversee biospecimen processing and storage.
• Develop and enforce quality management processes.
• Lead regulatory compliance with HIPAA, IATA, and IRB requirements.

Responsibilities

• Direct biobanking activities including biospecimen collection, accessioning, processing, storage, and chain-of-custody documentation.
• Oversee laboratory workflows and SOPs; improve efficiency and scalability.
• Ensure regulatory compliance and data governance for biospecimen use.

Job description

Advertising Summary: Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

https://vcujobs.com/why-richmond

Unit: School Of Medicine MBU

Department: Institute for Liver Disease

Duties & Responsibilities

The Stravitz-Sanyal Institute for Liver Disease and Metabolic Health (SSLI) is recruiting a Director of the Biorepository Core to provide strategic, scientific, and operational leadership for the Institute's integrated biobanking and biospecimen processing enterprise. The Biorepository Core supports internal investigators, multi-site clinical research programs, translational science initiatives, and an expanding portfolio of external academic and industry collaborators.

The Director will oversee all aspects of biorepository operations, including biospecimen acquisition, processing, storage, quality management, regulatory compliance, laboratory information management systems (LIMS), and pre-analytical laboratory workflows. The Director will work closely with Institute leadership to develop operational strategy, implement emerging technologies, optimize laboratory workflows, and ensure the highest standards of quality, regulatory compliance, and scientific integrity. This individual will also supervise laboratory personnel, manage complex projects, and support investigator-initiated and sponsored research from protocol development through clinical translation.

Strategic Leadership

• Serve as a member of the SSLI leadership team and provide strategic oversight of the Institute's biorepository and laboratory processing operations.
• Develop and implement the long-term vision, operational strategy, and growth plans for the Biorepository Core.
• Establish policies, procedures, and quality systems supporting cohort studies, investigator-initiated research, and external collaborations.
• Collaborate closely with scientific leadership, informatics, clinical operations, research administration, and external stakeholders to ensure operational excellence and alignment with Institute priorities.
• Lead development of data governance and biospecimen sharing policies.

Laboratory & Biorepository Operations

• Direct all biobanking activities including biospecimen collection, accessioning, processing, aliquoting, storage, inventory management, retrieval, distribution, and chain-of-custody documentation.
• Oversee pre-analytical biological specimen processing while ensuring specimen integrity and standardized laboratory practices.
• Develop, implement, and continuously improve laboratory workflows, SOPs, and quality management processes.
• Evaluate and implement new technologies and automation to improve laboratory efficiency and scalability.
• Monitor specimen quality metrics and operational performance across all SSLI collections.
• Troubleshoot operational bottlenecks and identify opportunities for process improvement.

Regulatory & Quality Oversight

• Ensure compliance with institutional policies and applicable federal, state, and international regulations governing human biospecimens and research data.
• Oversee laboratory compliance with HIPAA, biosafety, biohazard handling requirements, and applicable shipping regulations including IATA.
• Serve as the primary operational lead for the Institute's biorepository protocol and ensure its continued regulatory maintenance and compliance, including preparation and submission of protocol revisions, amendments/modifications, renewals or continuing reviews, and other required IRB submissions.
• Maintain current and accurate biorepository protocol documentation and ensure that specimen collection, processing, storage, use, data management, and sharing activities remain consistent with the IRB-approved protocol and applicable institutional requirements.
• Provide regulatory oversight of biospecimen requests and releases, ensuring that all required use protocols, IRB approvals or determinations, data/use agreements, and other applicable authorizations are in place and appropriately documented before specimens are pulled, transferred, or released for research use.
• Confirm that proposed specimen use is consistent with the permissions and limitations established by the applicable informed consent and biorepository protocol.
• Maintain documentation supporting specimen requests, approvals, and releases to ensure appropriate traceability and regulatory accountability.
• Monitor regulatory deadlines and proactively coordinate required submissions to prevent lapses in IRB approval or disruptions to biorepository activities.
• Work with Institute leadership, investigators, research staff, and applicable institutional offices to resolve regulatory questions and implement changes resulting from protocol revisions or evolving research requirements.
• Ensure compliance with Good Documentation Practices and applicable regulatory requirements including 21 CFR Part 11 where appropriate.
• Support implementation of policies addressing data privacy requirements including GDPR and applicable genetic privacy regulations such as GINA.

Laboratory Information Systems & Technology

• Oversee optimization, validation, and ongoing administration of the Laboratory Information Management System (LIMS).
• Partner with informatics teams to improve specimen tracking, workflow automation, reporting, and data integration.
• Support future development and enhancement of LIMS infrastructure and laboratory technologies.

Personnel & Project Management

• Supervise all biorepository and laboratory personnel.
• Recruit, mentor, develop, and evaluate scientific and technical staff.
• Foster a collaborative, inclusive, and high-performing laboratory culture.
• Manage multiple concurrent laboratory projects, institutional initiatives, and sponsored research programs.
• Develop staffing plans, operational budgets, growth projections, and resource allocation strategies.
• Participate in grant development and provide operational planning support for new research initiatives.

Scientific Support

• Support investigator-led research from study design through publication and clinical translation.
• Prepare scientific reports,