Associate IVD Scientist

ARC Regulatory combines specialist IVD/CDx clinical research expertise with laboratory services and software solutions to support Sponsors across the clinical trial lifecycle and accelerate global precision medicine studies.

Through its Dx CRO and Sponsor Delegation services, ARC supports the planning, delivery and oversight of global CDx clinical trials, acting as an extension of the Sponsor team and providing clear ownership and accountability across delegated activities.

ARC Laboratories, based in Belfast, Northern Ireland, provides in-house assay and clinical trial sample testing capabilities across IHC, qPCR, ELISA and NGS-based testing. The laboratory is UKAS ISO 15189 and CAP accredited, providing high-quality biomarker testing for precision medicine clinical trials.

ARC's Health Institution status, under the IVDR Article 5(5), provides a practical route for early-phase clinical trial sample testing in the EU and UK, helping reduce regulatory burden and enable faster sample testing for eligible studies.

ARC also combines its regulatory expertise with technology through ARC360® powered by AURA AI. ARC360® is a regulatory intelligence and submission collaboration platform scoped specifically for CDx clinical trials, bringing national regulatory requirements, submission workflows, document generation and project reporting into one place. AURA AI capabilities combine the speed of AI with human expertise to support structured, traceable and auditable regulatory outputs.

By connecting clinical research, laboratory and technology expertise, ARC helps Sponsors reduce complexity, manage risk and maintain control across their global precision medicine clinical trials.

Job Purpose

To be an integral member of ARC’s laboratory team, supporting the design, development and delivery of internal and client-facing in vitro diagnostic (IVD) and companion diagnostic (CDx) programmes.

Reporting to the Laboratory Manager, the Associate IVD Scientist will support assay development, optimisation, verification and validation, alongside clinical trial sample testing and laboratory operations. Working closely with experienced scientists and colleagues across ARC, the postholder will contribute to accurate, reliable scientific outputs while developing their technical expertise within a quality-driven laboratory environment.

Key responsibilities

• Support the optimisation, verification and validation of molecular diagnostic assays, including NGS, PCR and related technologies.
• Perform biomarker testing and sample analysis, ensuring accuracy, quality and adherence to approved protocols.
• Analyse experimental results and contribute to scientific reports, presentations and project documentation.
• Maintain accurate, complete and traceable laboratory records in accordance with quality systems and approved procedures.
• Carry out laboratory activities in line with applicable regulatory requirements, quality standards and health and safety procedures.
• Collaborate with Laboratory, Quality, Regulatory and Research Operations teams to support project delivery and client outcomes.
• Participate in structured training to develop expertise in assay validation, diagnostic development and laboratory operations.
• Keep informed of developments in molecular diagnostics, precision medicine and scientific best practice.
• Identify opportunities to improve laboratory processes, efficiency and quality.

What you’ll bring

We are looking for a scientifically minded individual with at least two years’ experience working within a laboratory environment, strong attention to detail and an interest in molecular diagnostics and precision medicine. Experience in next-generation sequencing (NGS) would be particularly advantageous.

Essential experience

• A BSc in Biological Sciences or another relevant scientific discipline.
• A minimum of two years’ experience working within a laboratory environment.
• Practical experience using molecular biology techniques, such as PCR.
• Practical experience in next-generation sequencing (NGS).
• A basic understanding of assay verification and validation principles.
• Awareness of quality and regulatory requirements within laboratory environments.
• The ability to record, analyse and report scientific data accurately.
• Strong organisational skills, with the ability to prioritise tasks and meet agreed deadlines.
• Effective communication skills and the ability to work collaboratively across different functions.
• A commitment to learning, continuous improvement and developing technical expertise.

It would be an advantage if you also have

• A postgraduate qualification, such as an MSc or PhD, in a Life Science or related field.
• Experience with immunohistochemistry (IHC), histology or biomarker testing.
• An understanding of IVDR, ISO 15189, CAP or related regulatory and quality frameworks.
• Exposure to precision medicine, molecular diagnostics or companion diagnostics.

Why this role matters

At ARC, laboratory services sit alongside deep clinical, regulatory and technology expertise. Your work will support the development and testing of diagnostics used in precision medicine clinical trials, helping our teams and customers deliver high-quality research and accelerate patient access to appropriate treatments.

“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”