Senior Scientist – Diagnostic Deployment

AstraZeneca GmbH; Cambridge; On-site; GBP 75,000 - 105,000; Full time

Job summary

AstraZeneca Cambridge is seeking a Senior Scientist to deliver tissue-based and digital diagnostics for clinical trial testing within our ADDL. You will lead development, validation, and operational delivery of assays, ensuring regulatory compliance and data integrity across end-to-end workflows.

The role requires expert histology/IHC skills, experience with LIMS and digital pathology, and a track record in regulated laboratory environments.

Qualifications

• Degree in Biomedical Science, Pathology, Life Sciences, or related discipline, or equivalent experience.
• Strong practical experience in histology and IHC in a regulated lab.
• Experience supporting routine lab operations, including workflow coordination and consumables management.
• Experience performing or overseeing prospective diagnostic testing or related clinical-study activities.
• Experience with LIMS/LIS and digital pathology.
• Knowledge of quality frameworks such as CAP/CLIA, ISO 15189, ISO 13485, IVDR, HTA, and HBS.
• Experience with controlled documentation, SOPs, deviations, CAPAs, and audit readiness.
• Strong data integrity and documentation skills.
• Excellent communication and cross-functional collaboration.
• Familiarity with cross-functional teams and project leadership.
• System integration in pathology workflows.
• Experience with analytical validation of histology or IHC-based assays.
• Familiarity with oncology precision medicine and companion diagnostics.
• HTA and HBS compliance in lab operations.
• Experience working with external labs or diagnostic partners.

Responsibilities

• Lead development, validation, and delivery of tissue-based assays with focus on reproducibility and clinical decision support.
• Design and execute analytical validation plans aligned with regulatory expectations.
• Apply whole-slide imaging and image analysis to strengthen assay scoring.
• Embed CAP/CLIA, ISO 15189, ISO 13485, IVDR, HTA, and HBS requirements in daily practice.
• Perform and oversee prospective diagnostic testing for clinical studies with GCP ICH adherence.
• Improve end-to-end workflows by integrating LIMS and related systems.
• Lead cross-functional scientific projects across clinical, regulatory, and quality teams.
• Drive continuous improvement and assess new tissue-based technologies for assay development.

Skills

Histology

Immunohistochemistry (IHC)

Lab operations

Diagnostic testing

LIMS

Digital pathology

Quality frameworks

Documentation control

Data integrity

Communication

Collaboration

System integration

Analytical validation

Precision diagnostics

HTA/HBS compliance

Audits & inspections

External partners

Education

Biomed/Pathology/Life Sciences degree or equivalent

Tools

LIMS/LIS

Digital pathology systems

Job description

Job Title: Senior Scientist – Diagnostic Deployment

Location: Cambridge, UK

Introduction to role:

Precision Diagnostics Development (PDD) within AstraZeneca focuses on matching medicines to those patients who will benefit most and delivering companion or complementary diagnostic assays aligned to drug development to enable personalised healthcare across our clinical portfolio.

We are seeking a Senior Scientist to join our Accredited Diagnostic Development Laboratory (ADDL) at the Cambridge Biomedical Campus, supporting the development, optimisation, validation, and operational delivery of tissue-based diagnostic assays for AstraZeneca's clinical portfolio. This role is suited to an experienced laboratory scientist with a strong histology and immunohistochemistry (IHC) background, knowledge of digital and computational pathology, and a track record of delivering high-quality, reproducible testing within a regulated laboratory environment.

You will play a hands-on role in the delivery of tissue-based and digital diagnostics that support clinical trial testing and assay deployment, combining technical excellence with the scientific rigour required to operate within accredited quality frameworks. In this role, you will also contribute to the integration of key systems across our end-to-end workflow, including LIMS, and collaborate across the broader process to identify opportunities for optimisation, efficiency, and streamlining.

Accountabilities:

• Histology and IHC Delivery: Lead development, optimisation, validation, and operational delivery of tissue-based assays, setting the technical standard for consistency, turnaround time, and reproducibility that underpins clinical decision-making.
• Assay Validation: Design and execute analytical validation plans aligned with study needs and regulatory expectations, moving assays efficiently from development into prospective clinical testing.
• Digital and Computational Pathology: Apply whole-slide imaging and image analysis to strengthen assay scoring and interpretation; evaluate emerging digital capabilities to expand our diagnostic toolkit.
• Quality and Compliance: Embed CAP/CLIA, ISO 15189, ISO 13485, IVDR, HTA and HBS requirements in day-to-day practice, including SOP authorship, deviation/CAPA management, and audit readiness, so our lab remains inspection-ready and trusted.
• Clinical Trial Testing Support: Perform and oversee prospective diagnostic testing for clinical studies, ensuring GCP ICH adherence, sample integrity, accurate data capture, and dependable reporting timelines.
• Process Engineering and System Integration: Improve end-to-end laboratory workflows by integrating LIMS and related systems, enhancing data flow, operational efficiency, and robustness from assay development through clinical testing.
• Scientific Collaboration: Lead cross-functional scientific projects with clinical, laboratory, regulatory, and quality colleagues; articulate risks and mitigations clearly to align assay strategy with program objectives.
• Continuous Improvement and Scientific Innovation: Drive a culture of scientific excellence by assessing new tissue-based technologies and translating promising ideas into practical assay development plans that advance our oncology portfolio.

Essential Skills/Experience:

• Degree in Biomedical Science, Pathology, Life Sciences, or a related discipline, or equivalent relevant experience.
• Strong practical experience in histology and immunohistochemistry (IHC) in a regulated laboratory environment.
• Experience supporting routine laboratory operations, including workflow coordination, sample handling, reagent readiness, and consumables management.
• Experience performing or overseeing prospective diagnostic testing or related clinical-study laboratory activities.
• Experience of laboratory information systems (LIMS/LIS) and digital pathology.
• Knowledge of relevant quality and compliance frameworks, including CAP/CLIA, ISO 15189, ISO 13485, ISO 14971, IVDR, HTA, and HBS, as applicable.
• Experience with controlled documentation, including SOPs, deviations, CAPAs, and audit/inspection readiness.
• Strong data integrity, documentation, and record-keeping skills.
• Strong communication and collaboration skills, with the ability to work effectively across cross-functional teams.

Desirable Skills/Experience:

• HCPC registration, MIBMS or FIBMS, or equivalent professional accreditation.
• Experience in an accredited diagnostic laboratory, including CAP/CLIA or ISO 15189.
• Experience of digital systems integration in a pathology setting
• Experience leading analytical validation of histology or IHC-based assays.
• Familiarity with oncology precision medicine and companion/complementary diagnostics.
• Practical experience with HTA and HBS compliance in laboratory operations.Experience supporting audits, inspections, or accreditation activities.
• Experience working with external laboratories or diagnostic partners.

Why AstraZeneca:

Here, diagnostics shape the future of cancer care. You will work at the intersection of pathology, data science, and clinical development, advancing novel biomarkers and AI-enabled image analysis to identify patients who benefit most from our broad pipeline of new therapies. Expect to collaborate in unexpected combinations-scientists, engineers, and clinicians around the same slide image—translating rigorous laboratory science into real-world clinical impact. We pair bold goals with practical support, valuing curiosity and kindness alongside ambition, so you can move fast, learn deeply, and see your work change the practice of medicine.

Date Posted

11-Aug-2026

Closing Date

29-Aug-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.