Biobank Director: Lead Growth, Compliance & Research

OneOncology, LLC; Shirley (NY); Sur place; USD 117 000 - 143 000; Plein temps

Résumé du poste

New York Cancer & Blood Specialists seeks an experienced Biobank Director to oversee operations, quality, compliance, and growth of the biobanking program. You will optimize specimen-management, maintain accreditation, and drive new business opportunities, delivering reliable, high-quality services.

Responsibilities include leading daily operations, developing SOPs, supervising staff, and ensuring CAP/FDA/ICH compliance.

Qualifications

• Bachelor's degree in biology, biochemistry, pathology, cell biology, or a related scientific discipline required; master’s degree preferred.
• Experience supervising staff and leading teams in biospecimen handling or biobanking environments.
• Advanced knowledge of specimen collection, processing, storage, annotation, and shipping.
• Experience with specimen inventory-tracking databases and laboratory information management systems (LIMS).
• IATA training and working knowledge of CAP, FDA, NYSDOH, GCP, ICH standards.

Responsabilités

• Lead the 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.

Connaissances

Leadership

Regulatory compliance knowledge

Analytical skills

Biospecimen knowledge

Project management

Formation

Bachelor's degree in biology/biochemistry/pathology/cell biology or related

Master's degree preferred

Outils

Microsoft Excel

Project

PowerPoint

Word

Visio

LIMS / Laboratory Information Management System

Description du poste

New York Cancer & Blood Specialists seeks an experienced Biobank Director to oversee operations, quality, compliance, and growth of the biobanking program. You will optimize specimen-management, maintain accreditation, and drive new business opportunities, delivering reliable, high-quality services.

Responsibilities include leading daily operations, developing SOPs, supervising staff, and ensuring CAP/FDA/ICH compliance.