Director, Biorepository Core

Virginia Commonwealth University (VCU) School of Medicine, a premier academic medical center in Richmond, is seeking a Director of the Biorepository Core to lead the Institute for Liver Disease and Metabolic Health’s integrated biobanking and biospecimen processing enterprise.

Responsibilities

• 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 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.

Requirements

• 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.
• 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

Pay

$120,000-$180,000; commensurate with experience.

Benefits

• Comprehensive health benefits.
• Paid annual and holiday leave.
• Generous tuition benefits.
• Retirement planning and savings options, including tax-deferred annuity and cash match programs.
• Employee discounts.
• Well-being resources.
• Abundant opportunities for career development and advancement.