Director, Biorepository Core

Virginia Commonwealth University; Richmond (VA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Paid annual and holiday leave

Tuition benefits

Retirement options

Job summary

Virginia Commonwealth University in Richmond seeks a Director of the Biorepository Core within the Stravitz-Sanyal Institute for Liver Disease to provide strategic, scientific, and operational leadership for biobanking and biospecimen processing.

You will oversee all biobanking activities, ensure regulatory compliance, manage personnel, and partner with Institute leadership to advance translational research.

Qualifications

• Master's degree in Biological Sciences or related field required.
• Ph.D. in Biological Sciences preferred.
• Minimum 10 years in biobanking/biorepository operations.
• Minimum 5 years of supervisory experience.
• Experience with IRB submissions and regulatory processes.
• Strong leadership and project management skills.

Responsibilities

• Direct all biobanking activities including biospecimen collection, processing, storage and chain-of-custody.
• Oversee pre-analytical processing and maintain specimen integrity.
• Develop SOPs, quality management, and process improvements.
• Lead laboratory workflows, regulatory compliance, and data governance.
• Supervise personnel and manage multiple concurrent projects.
• Support investigator-led research from protocol to clinical translation.

Skills

Biobanking operations

Laboratory management

Regulatory compliance

Leadership

Project management

LIMS

HIPAA / data privacy

IRB submissions

Quality systems

Biospecimen lifecycle

Education

Master's degree in Biological Sciences

Ph.D. preferred

Tools

LIMS

IRB submissions tools

Job description

Advertising Summary:

Virginia Commonwealth University (VCU)School of Medicine is a premier academic medical center located inthe heart of Richmond. Accounting for almost half of VCU’ssponsored research, the School of Medicine is internationallyrecognized for patient care and education. Virginia CommonwealthUniversity 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 MetabolicHealth (SSLI) is recruiting a Director of the BiorepositoryCore to provide strategic, scientific, and operationalleadership for the Institute's integrated biobanking andbiospecimen processing enterprise. The Biorepository Core supportsinternal investigators, multi-site clinical research programs,translational science initiatives, and an expanding portfolio ofexternal academic and industry collaborators.

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

Strategic Leadership

• Serve as a member of the SSLI leadership team and providestrategic oversight of the Institute's biorepository and laboratoryprocessing operations.
• Develop and implement the long-term vision, operationalstrategy, and growth plans for the Biorepository Core.
• Establish policies, procedures, and quality systems supportingcohort studies, investigator-initiated research, and externalcollaborations.
• Collaborate closely with scientific leadership, informatics,clinical operations, research administration, and externalstakeholders to ensure operational excellence and alignment withInstitute priorities.
• Lead development of data governance and biospecimen sharingpolicies.

Laboratory & Biorepository Operations

• Direct all biobanking activities including biospecimencollection, accessioning, processing, aliquoting, storage,inventory management, retrieval, distribution, and chain-of-custodydocumentation.
• Oversee pre-analytical biological specimen processing whileensuring specimen integrity and standardized laboratorypractices.
• Develop, implement, and continuously improve laboratoryworkflows, SOPs, and quality management processes.
• Evaluate and implement new technologies and automation to improve laboratory efficiency and scalability.
• Monitor specimen quality metrics and operational performanceacross all SSLI collections.
• Troubleshoot operational bottlenecks and identify opportunitiesfor process improvement.

Regulatory & Quality Oversight

• Ensure compliance with institutional policies and applicablefederal, state, and international regulations governing humanbiospecimens and research data.
• Oversee laboratory compliance with HIPAA, biosafety, biohazardhandling requirements, and applicable shipping regulationsincluding IATA.
• Serve as the primary operational lead for the Institute'sbiorepository protocol and ensure its continued regulatorymaintenance and compliance, including preparation and submission ofprotocol revisions, amendments/modifications, renewals orcontinuing reviews, and other required IRB submissions.
• Maintain current and accurate biorepository protocoldocumentation and ensure that specimen collection, processing,storage, use, data management, and sharing activities remainconsistent with the IRB-approved protocol and applicableinstitutional requirements.
• Provide regulatory oversight of biospecimen requests andreleases, ensuring that all required use protocols, IRB approvalsor determinations, data/use agreements, and other applicableauthorizations are in place and appropriately documented beforespecimens are pulled, transferred, or released for researchuse.
• Confirm that proposed specimen use is consistent with thepermissions and limitations established by the applicable informedconsent and biorepository protocol.
• Maintain documentation supporting specimen requests, approvals,and releases to ensure appropriate traceability and regulatoryaccountability.
• Monitor regulatory deadlines and proactively coordinaterequired submissions to prevent lapses in IRB approval ordisruptions to biorepository activities.
• Work with Institute leadership, investigators, research staff,and applicable institutional offices to resolve regulatoryquestions and implement changes resulting from protocol revisionsor evolving research requirements.
• Ensure compliance with Good Documentation Practices andapplicable regulatory requirements including 21 CFR Part 11 whereappropriate.
• Support implementation of policies addressing data privacyrequirements including GDPR and applicable genetic privacyregulations such as GINA.

Laboratory Information Systems & Technology

• Oversee optimization, validation, and ongoing administration ofthe 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 LIMSinfrastructure and laboratory technologies.

Personnel & Project Management

• Supervise all biorepository and laboratory personnel.
• Recruit, mentor, develop, and evaluate scientific and technicalstaff.
• Foster a collaborative, inclusive, and high-performinglaboratory culture.
• Manage multiple concurrent laboratory projects, institutionalinitiatives, and sponsored research programs.
• Develop staffing plans, operational budgets, growthprojections, and resource allocation strategies.
• Participate in grant development and provide operationalplanning support for new research initiatives.

Scientific Support

• Support investigator-led research from study design throughpublication 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 disciplinerequired.
• Ph.D. in Biological Sciences or a related field preferred.
• Minimum of 10 years of progressively responsible experience inbiobanking, biorepository operations, or biological laboratorymanagement.
• Minimum of 5 years of supervisory or personnel managementexperience.
• Demonstrated experience leading complex laboratory operationsand multidisciplinary teams.
• Extensive experience managing biobanking operations andbiospecimen lifecycle management.
• Experience with biological specimen processing andpre-analytical laboratory workflows.
• Experience preparing and managing IRB submissions, amendments,and continuing reviews.
• Experience supervising scientific and technical personnel.
• Experience developing, implementing, and maintaining StandardOperating Procedures (SOPs).
• Experience with Laboratory Information Management Systems(LIMS).
• Strong project management skills with the ability to overseemultiple complex initiatives simultaneously.
• Experience handling biohazardous materials in accordance withapplicable regulations and institutional policies.
• Working knowledge of HIPAA regulations governing protectedhealth information.
• Experience with IATA regulations for shipment of biologicalmaterials or ability to obtain certification upon hire.
• Strong written and verbal communication skills, includingpreparation of scientific reports, presentations, and executivebriefings using Microsoft PowerPoint.
• Strong understanding of laboratory operations, biobanking bestpractices, and research infrastructure.
• Excellent organizational, analytical, and problem-solvingskills.
• Demonstrated leadership and personnel managementabilities.
• Ability to effectively prioritize competing responsibilitiesand manage multiple concurrent projects.
• Strong interpersonal skills with the ability to buildcollaborative relationships across multidisciplinary teams.
• Excellent written, verbal, and presentation skills.
• Experience developing operational workflows and drivingcontinuous process improvement.
• Ability to interpret and apply complex regulatory and researchcompliance requirements.
• Demonstrated ability to work in and foster an environment ofrespect, professionalism and civility with a population of faculty,staff, and students from all backgrounds and experiences, or acommitment to do so as a staff member at VCU.

Preferred Qualifications

• Histology and tissue processing.
• Molecular biology techniques including DNA and RNAextraction.
• Next-generation sequencing workflows including librarypreparation.
• 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 translationalresearch.

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'speriod(s) of military service in the calculation of their annualleave accrual rate. This may provide veterans with an increasedleave accrual!

Salary Range:

$120,000-$180,000; commensurate withexperience & 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 positionis Director, Biorepository Core. The institutional job title isSenior Administrator, Research Services (Sr. Administrator, RS),consistent with the University's job classification structure andthe position's current supervisory scope. The working titlereflects the position's responsibility for strategic andoperational leadership of the Biorepository . As the Biorepositorygrows and the position's scope, organizational complexity, andnumber of direct-report managers evolve, the position may bereviewed for potential reclassification in accordance withUniversity classification guidelines and applicable HRprocesses.