Biorepository Operations Manager – On‑Site Lead, CAP Ready

BioSpace; Durham (NC); On-site; USD 100,000 - 133,000; Full time

Benefits offered by this job

Flexible time-off

401(k) match

Medical, dental, and vision coverage

Mindfulness programs

Job summary

GRAIL is seeking a Manager, Biorepository Operations to lead the on‑site and off‑site biorepository activities at the Durham, NC office. You will oversee specimen management for ~1 million samples, ensure regulatory compliance, and drive CAP accreditation readiness.

This hands‑on leadership role requires collaboration with Facilities, Quality, Clinical Operations, IT, and external vendors to support operations and business continuity.

Qualifications

• Bachelor’s degree in a science‑related field is required.
• Advanced degree (Master’s) preferred.
• 8+ years of relevant laboratory or biorepository experience with 3–5 years in a supervisory role.
• Experience with CAP Biorepository Accreditation Program requirements is preferred.
• Experience managing third‑party storage vendors and international operations is preferred.
• Experience with LIMS or standalone biorepository software is required.

Responsibilities

• Oversee daily biorepository operations including receipt, accessioning, processing, storage, retrieval, shipment, and disposal.
• Manage inventory for approximately 1 million specimens across on‑site and off‑site locations.
• Lead relationships with domestic and international storage vendors and ensure compliance and inventory integrity.
• Ensure chain‑of‑custody documentation and specimen traceability across workflows.
• Develop and maintain SOPs, workflows, and best practices for regulatory compliance.
• Lead CAP Biorepository Accreditation activities including audits and CAPA.

Skills

Leadership

Regulatory compliance

Biorepository knowledge

Vendor management

Data analysis

Education

Bachelor’s degree in science

Master’s degree preferred

Tools

LIMS

Biorepository software

Job description

GRAIL is seeking a Manager, Biorepository Operations to lead the on‑site and off‑site biorepository activities at the Durham, NC office. You will oversee specimen management for ~1 million samples, ensure regulatory compliance, and drive CAP accreditation readiness.

This hands‑on leadership role requires collaboration with Facilities, Quality, Clinical Operations, IT, and external vendors to support operations and business continuity.