Description
- Lead and manage sample management and storage operations group.
- Supervise, mentor, and develop staff, including training and performance management
- Establish staffing plans and workflows to support study timelines, repository processes and receipt tracking, and business needs
- Oversee receipt, accessioning, labeling, storage, retrieval, disposition and archival of biological samples
- Ensure accurate sample tracking using LIMS and associated inventory systems
- Manage sample shipments (domestic and international), including chain of custody and temperature-controlled logistics
- Ensure sample accessioning occurs accurately and swiftly
- Respond directly to client and internal requests about received and held samples.
- Develop, implement, and continuously improve efficient and compliant business processes to support current and future needs of the group.
- Lead the generation of revenue from sample management and biorepository activities and be responsible for reaching or exceeding revenue targets
- Ensure compliance with GxP, GLP, GCP, and applicable regulatory requirements
- Author, review, and approve SOPs, work instructions, and controlled forms
- Support internal and external audits, inspections, and regulatory inquiries
- Partner with Quality Assurance to manage deviations, CAPAs, and process
Requirements
· Bachelor’s degree in Life Sciences or a related discipline
· 5–8+ years of experience in sample management and/or biorepository operations.
· 3+ years of people management or team leadership experience in sample management or biorepository operations
· Strong working knowledge of GxP regulations and sample chain-of-custody requirements
· Experience with LIMS and electronic sample tracking systems. Experience in Watson is a plus.
· Demonstrated ability to manage revenue, budgets and implement new processes in a sample management and storage group.
· Excellent organizational, communication, and problem-solving skills
· Experience supporting global clinical trials and international sample shipments
Summary
The Associate Director, Sample Management and Storage, is responsible for end-to-end logistical and financial leadership for all aspects of biological sample handling, accession, storage, tracking, and disposition in support of bioanalytical, ADME and biomarker studies. This role provides operational and financial leadership to the Sample Management team, ensures compliance with GxP and regulatory requirements, revenue leadership for sample management and repository activities and partners closely with laboratory, quality, and study management teams and clients to support on-time and high-quality study execution.