Biobank Director: Lead Operations & Compliance

New York Cancer & Blood Specialists; Shirley (AL); On-site; USD 117,000 - 143,000; Full time

Job summary

New York Cancer & Blood Specialists seeks a Biobank Director to oversee operations, quality, regulatory compliance, and growth of our biobanking program. You will optimize specimen-management processes, ensure accreditation, and drive new business opportunities.

You will lead daily operations, maintain CAP/FDA/I H standards, and manage staff while building strategic partnerships with sponsors and collaborators to advance research and patient care.

Qualifications

• Bachelor’s degree in biology, biochemistry, pathology, cell biology, or a related scientific discipline required; master’s degree preferred.
• At least five years of progressive experience in a biospecimen procurement or biobanking environment.
• Previous supervisory experience with leadership and staff-development capabilities.
• Advanced knowledge of specimen collection, processing, storage, annotation, and shipping.
• Experience working with specimen inventory-tracking databases and laboratory information management systems.
• IATA training required.
• Working knowledge of CAP, FDA, NYSDOH, GCP, ICH, and other applicable standards.
• Proficiency with Microsoft Excel, Project, PowerPoint, Word, and Visio.
• Excellent analytical, critical-thinking, and problem-solving skills.
• Reliable transportation required.

Responsibilities

• Lead daily operations and strategic growth of the Biobank.
• Remain current on emerging biobanking technologies and establish methods, protocols, and service standards that improve operations.
• Evaluate utilization, productivity, service quality, and financial performance to identify opportunities for improvement.
• Develop relationships with sponsors and promote the Biobank’s services to support new business development.
• Collect and report specimen-management metrics to support forecasting and operational decision-making.
• Oversee specimen collection, processing, storage, annotation, shipping, and inventory management.
• Manage cold-storage units, environmental-monitoring systems, and contingency plans for unexpected events.
• Participate in a rotating on-call schedule for environmental monitoring and emergency response.
• Maintain compliance with CAP, FDA, NYSDOH, GCP, ICH, and other applicable regulations.
• Maintain the New York State license for non-transplant anatomic bank operations.
• Lead the application and ongoing maintenance of College of American Pathologists Biorepository Accreditation.
• Develop, review, and maintain standard operating procedures.
• Conduct audits, root-cause analyses, and corrective-action initiatives.
• Resolve specimen-management issues and respond to operational inquiries.
• Supervise, train, and evaluate Biobank staff while promoting a collaborative research environment.
• Assess staffing needs and participate in hiring, performance management, and termination processes.

Skills

Biobank leadership

Staff supervision

Data analysis

Excel

Project management

LIMS

Regulatory compliance

Problem solving

Communication

Transportation

Education

Bachelor's degree in biology/biochemistry/pathology

Master's degree preferred

Tools

LIMS

Microsoft Visio

Microsoft Excel

Regulatory databases

Job description

New York Cancer & Blood Specialists seeks a Biobank Director to oversee operations, quality, regulatory compliance, and growth of our biobanking program. You will optimize specimen-management processes, ensure accreditation, and drive new business opportunities.

You will lead daily operations, maintain CAP/FDA/I H standards, and manage staff while building strategic partnerships with sponsors and collaborators to advance research and patient care.