Biorepository Manager
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Has the responsibility and accountability for all technical and supports all administrative and personnel matters required for the efficient and high-quality operation and management of the Biorepository. Has the responsibility for development, interpretation and application of section policies and procedures, and long-range planning in conjunction with the Biorepository Directors. Is responsible for working with Biorepository leadership to ascertain client needs, develop specimen processing protocols, and evaluating services to ensure the Biorepository is providing state of the art sample processing, storage, and distribution services. Is responsible for training of personnel, documentation of staff competency, and execution of biorepository services.
Manages and directs the daily operations of the Biorepository, including approving work schedules, maintaining proper staffing, and supervising the daily work activities of research associates in the Biorepository. Responsible for producing laboratory procedures and policies and reviewing these documents as required by regulatory agencies or as needed for supporting laboratory operations. Documents and reviews the Biorepository's technical performance in support of research studies and other service requests. Ensures appropriateness of specimen retrieval requests in coordination with Biorepository leadership. Works with Biorepository technical staff to ensure specimen requests are fulfilled promptly and according to standard operating procedures. Reviews study requests and support activities with biorepository leadership to determine feasibility, timeframe, and cost estimates. Interfaces with data scientists assigned to the Biorepository to ensure appropriate sample and data selection algorithms are used to support research sample requests. Ensures the Biorepository's practices and procedures are compliant with regulatory guidelines and meet the standards of the College of American Pathologists (CAP). Adheres to all Hazcom, Universal Precautions, fire and safety policies and procedures. Responsible for annual staff retaining for all safety policies. Assists in preparation of developing QA standards and indicators as appropriate for the Biorepository. Ensures adequate laboratory supplies and sound inventory control within budget parameters. Ensures that all Biorepository laboratory equipment is properly maintained to include service contractual arrangements and facilitates repair when necessary. Responsible for ensuring temperature monitoring is ongoing and reviewed promptly. Takes corrective action when needed due to unacceptable temperature deviations of laboratory equipment. Participates in the selection and motivation of all laboratory personnel. Responsible for review and update of job descriptions as needed. Responsible for monitoring technical competency of technical personnel to include annual competency evaluation as per CAP regulations. Assists Biorepository leadership in development of capital and operating budget plans. Coordinates billing activities of the Biorepository with leadership team. Maintains membership in necessary professional societies and attends professional meetings as appropriate. Responsible for participating in the development and evaluation of new methodologies and technologies for use in the Biorepository.
Required Skills and Abilities
1. Proven success managing complex laboratory and biorepository operations, including Clinical Chemistry, Microbiology, Molecular Diagnostics, and Biobanking. Advanced proficiency in high-complexity laboratory techniques such as nucleic acid extraction, cell separation methods, sample processing, cell culture/sterile technique, and serological methods, sample workflow optimization, and operational efficiency.
2. Demonstrated ability to recruit, train, supervise, and evaluate technical and administrative staff. Skilled in performance management, employee development, coaching, and disciplinary processes while fostering a collaborative and productive work environment.
3. Comprehensive knowledge of laboratory regulatory requirements, quality assurance/quality improvement programs, and process improvement methodologies. Proven ability to ensure compliance, maintain operational excellence, and implement efficient workflows.
4. Strong project management and organizational skills with the ability to balance competing priorities, manage laboratory growth initiatives, and collaborate effectively with clinicians, researchers, vendors, and institutional partners. Demonstrated strategic thinking and independent decision-making.
5. Proven experience managing laboratory budgets, overseeing fiscal operations, and ensuring financial accountability. Proficient in laboratory information systems and databases and Microsoft Office applications to support reporting, analysis, and operational management.
Preferred Skills and Abilities
1. Master's Degree in a scientific discipline and eight years of experience or an equivalent combination of education and experience.
2. Advanced technical, managerial, computer, analytical, organizational and training skills.
3. Proven experience managing biorepositories. MT (ASCP) or similar certification.