Biocenter Biobank Operations Manager

AstraZeneca•Gaithersburg, MD

2d•$142,378 - $213,566•Onsite

About The Position

Human Biological Samples (HBS) are fundamental to medical research in discovering, developing and implementing new treatments and diagnostics. They are ethically sensitive materials and underpin the delivery of every clinical trial. The Biocenter Biobank Operations Manager is responsible for the day-to-day operational management of biobank activities within the Biocenter, ensuring compliant, efficient, and high-quality delivery of biosample handling and biobanking support to scientific and clinical stakeholders. Reporting to the Biocenter Biobank Lead, this role oversees operational execution across sample receipt, handling, storage, tracking, retrieval, transfer coordination, and inventory control, while supporting inspection readiness, staff coordination, and continuous process improvement.

Requirements

Bachelors/Masters in scientific discipline
Minimum of 5 years of relevant experience in the Biobanking industry
Demonstrated leadership skills including strategic planning
Expert knowledge on ethical and regulatory aspects of biobanking and sample usage
Understanding of GCP and understanding of applicable regional regulations
Thorough understanding of, and experience with, working with various IT solutions, such as LIMS systems and databases
Fluent in English as the AstraZeneca working language

Nice To Haves

knowledge of Regulatory areas- FDA, CLIA, ISO
Excellent team working and networking skills with experience of interacting effectively across interfaces of discipline, culture, and expertise.
Excellent decision-making and communication skills, scientific judgement and analytical skills
Strong ability to work independently
Willingness to take decisions and find solutions

Responsibilities

Accountable for day-to-day biobank operations within the Biocenter, ensuring timely, compliant, and high-quality support to scientific and clinical functions
Oversee operational workflows related to sample receipt, accessioning, handling, processing coordination, storage, tracking, retrieval, transfer coordination, and disposition in accordance with approved procedures and study requirements
Support and coordinate sample handling activities, ensuring biospecimen workflows are executed in compliance with approved processes, protocol requirements, and applicable regulations
Monitor and manage biobank sample inventory in alignment with global standards, ensuring samples are stored appropriately, tracked accurately, and disposed of in accordance with approved retention and destruction requirements
Ensure work is performed in accordance with global standards including Safety, SOPs, Good Clinical Practice, and applicable legal and regulatory requirements
Maintain operational inspection readiness and support audits and inspections through documentation, process adherence, issue follow-up, and implementation of corrective and preventive actions as required
Identify, assess, escalate, and manage day-to-day operational risks, issues, deviations, and delivery challenges affecting biobank operations
Ensure effective operational use of LIMS, databases, and sample tracking systems, and support compliance with AZ data standards, procedural requirements, and applicable regulations
Develop work schedules and coordinate staffing plans to support workload balancing, operational continuity, and delivery against business priorities
Supervise, train, coach, and mentor biobank scientists and/or operational staff to maintain high standards of performance, technical capability, and compliance
Provide operational expertise in biobanking and end-to-end sample management, supporting science functions and escalating strategic or policy matters to the Biocenter Biobank Lead where appropriate
Work closely with compliance teams, clinical sampling teams, researchers, and other relevant stakeholders to support smooth execution of biosample operations and resolution of operational issues
Lead or support continuous improvement initiatives to strengthen biobank operations, efficiency, quality, consistency, and automation where applicable
Support implementation of global biobank processes, standards, and ways of working within the Biocenter, ensuring local adoption and alignment
Track, analyze, and report local operational metrics related to sample operations, quality, compliance, and service delivery
Provide input into procedural documents, local working instructions, and operational documentation to support compliant and efficient biobank operations