Biobank Scientist Full-time NEW

Senior Biobank Scientist

Location: Gaithersburg, MD, USA

Human Biological Samples (HBS) are fundamental to medical research and underpin the delivery of clinical trials. The Senior Biobank Scientist is responsible and accountable for maintaining the HBS inventory in line with Global Standards, Good Clinical Practice (GCP), and Standard Operating Procedures (SOPs). The role ensures compliant sample handling across receipt, logging, storage, tracking, processing, dispatch, return, and disposal, using specialised IT systems and databases, and maintaining daily communication with HBS users and stakeholders. The role also leads process and IT improvement activities, manages relationships with key stakeholders, provides local training to science partners, liaises with external vendors, and advises on HBS availability and sources. This position plays a key role in coordinating Biobank site operations by delivering HBS processing capabilities, with a particular focus on sectioning, staining, and scanning.

Key responsibilities

• Receive and register incoming HBS, ensuring traceability and compliance with global standards and regulatory requirements.
• Process customer requests for HBS and manage the end-to-end sample workflow: receipt, logging, storage, tracking, processing, dispatch, return, and disposal.
• Act as the first escalation point for histology issues, applying expertise to resolve problems.
• Perform histology activities including microtomy, a range of staining methodologies, and evaluation of process challenges.
• Perform aliquoting or sectioning (and other histology techniques) of HBS.
• Track work-in-progress using specialised informatics systems and databases to maintain clear status visibility.
• Contribute to lab training/education; maintain histology and microtomy areas, relevant SOPs, equipment maintenance, COSHH guidelines, and risk assessments; follow SHE procedures and applicable regulations.
• Identify, lead, and deliver continuous improvement initiatives (process and/or IT), including root cause investigation and escalation as required.
• Communicate with internal science partners (customers) to ensure compliance with the global HBS standard and legal requirements (HTA where applicable).
• Collaborate with global biobank teams and internal/external stakeholders to drive continuous improvement.
• When applicable: provide technical support in microtomy, cryosectioning, routine histological staining, immunohistochemistry staining, slide scanning, and digital image analysis; and provide aliquoting support (including automated aliquoting).
• May occasionally be required to work weekends or out of hours.

Education, skills & experience

Essential

• Degree in a scientific discipline with required experience: Bachelor's degree + 5 years of relevant experience (5 YOE) OR Master's degree + 2 years of relevant experience (2 YOE).
• Experience in biobanking and working with HBS.
• Fully competent in histology techniques such as microtomy and a variety of staining methodologies, with the ability to assess and manage process challenges.
• Fluent in English (AstraZeneca working language).
• Excellent communication skills and strong attention to detail.
• Experience with IT solutions (e.g., LIMS systems and databases) and strong Excel capability for data transformation and analysis.
• Strong problem-solving skills, including investigating and escalating issues.
• Strong collaboration, partnering, and interpersonal skills.

Desirable

• Experience managing complex projects.
• Clinical laboratory scientific experience; RMS experience.
• Experience with archiving of study-based materials (raw data, images, FFPE blocks and slides) and maintaining audit-ready electronic records.
• Automation experience with equipment such as Hamilton STAR.
• Histopathology experience.
• Strong influencing skills and willingness to challenge stakeholders to maintain or improve processes.

AstraZeneca offers an inspiring learning environment where every setback is seen as a chance to improve. Our supportive yet challenging approach pushes us towards groundbreaking solutions. We are dedicated experts who combine specialist knowledge with curiosity, always searching for better ways of doing things. Working here means contributing to something that truly matters—using our skillset to make an important difference to society and patients across the globe.