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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, operational metrics, presentations, and executive-level communications.
• Participate in institutional committees, leadership meetings, and strategic initiatives.

Qualifications:

Minimum Qualifications

• Master's degree in Biological Sciences, Molecular Biology, Biochemistry, Biomedical Sciences, or a closely related discipline required.
• Ph.D. in Biological Sciences or a related field preferred.
• Minimum of 10 years of progressively responsible experience in biobanking, biorepository operations, or biological laboratory management.
• Minimum of 5 years of supervisory or personnel management experience.
• Demonstrated experience leading complex laboratory operations and multidisciplinary teams.
• Extensive experience managing biobanking operations and biospecimen lifecycle management.
• Experience with biological specimen processing and pre-analytical laboratory workflows.
• Experience preparing and managing IRB submissions, amendments, and continuing reviews.
• Experience supervising scientific and technical personnel.
• Experience developing, implementing, and maintaining Standard Operating Procedures (SOPs).
• Experience with Laboratory Information Management Systems (LIMS).
• Strong project management skills with the ability to oversee multiple complex initiatives simultaneously.
• Experience handling biohazardous materials in accordance with applicable regulations and institutional policies.
• Working knowledge of HIPAA regulations governing protected health information.
• Experience with IATA regulations for shipment of biological materials or ability to obtain certification upon hire.
• Strong written and verbal communication skills, including preparation of scientific reports, presentations, and executive briefings using Microsoft PowerPoint.
• Strong understanding of laboratory operations, biobanking best practices, and research infrastructure.
• Excellent organizational, analytical, and problem-solving skills.
• Demonstrated leadership and personnel management abilities.
• Ability to effectively prioritize competing responsibilities and manage multiple concurrent projects.
• Strong interpersonal skills with the ability to build collaborative relationships across multidisciplinary teams.
• Excellent written, verbal, and presentation skills.
• Experience developing operational workflows and driving continuous process improvement.
• Ability to interpret and apply complex regulatory and research compliance requirements.
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.

Preferred Qualifications

Experience with one or more of the following is highly desirable:

• Histology and tissue processing.
• Molecular biology techniques including DNA and RNA extraction.
• Next-generation sequencing workflows including library preparation.
• Omics technologies including genomics, transcriptomics, proteomics, metabolomics, or single-cell analyses.
• LIMS architecture, system design, implementation, validation, and administration.
• Laboratory automation technologies.
• Quality management systems supporting translational research.

Knowledge of the following regulatory frameworks is a plus:

• 21 CFR Part 11
• HIPAA
• GDPR (General Data Protection Regulation)
• Genetic Information Nondiscrimination Act (GINA)
• Biosafety and biohazard handling regulations
• IATA Dangerous Goods Regulations for biological specimens
• Human subjects research regulations and IRB processes

Position will remain open until filled.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

Salary Range: $120,000-$180,000; commensurate with experience & job slotting

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt

Restricted Position: No

ORP Eligible: Yes

Flexible Work Arrangement: Fully Onsite

University Job Title: 3291S - Sr Administrator RS Senior: Senior Administrator, RS 1-3 (32914Y-32916Y)

Position Classification Note: The working title for this position is Director, Biorepository Core. The institutional job title is Senior Administrator, Research Services (Sr. Administrator, RS), consistent with the University's job classification structure and the position's current supervisory scope. The working title reflects the position's responsibility for strategic and operational leadership of the Biorepository . As the Biorepository grows and the position's scope, organizational complexity, and number of direct-report managers evolve, the position may be reviewed for potential reclassification in accordance with University classification guidelines and applicable HR processes.