R&D Scientist | ARC Regulatory

About ARC

ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.

We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.

ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.

To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.

Job Purpose

To be an integral member and significant contributor to ARCs laboratory team in the design, implementation and execution of internal and client laboratory IVD or CDX studies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of regulated experimental approaches to clinical studies, internal and external stakeholder satisfaction as well as an innate work ethic that aligns with the company’s core values.

Key Responsibilities:

The R&D Scientist is expected to:

Develop, optimise and validate assay protocols for molecular assays including PCR and Next generation Sequencing

Conduct experiments to troubleshoot and refine processes to improve assay sensitivity, specificity, and reproducibility.

Conduct analysis of biomarker levels in biological samples.

Analyse and interpret experimental data, preparing comprehensive reports and presentations for stakeholders.

Stay updated with the latest advancements in relevant scientific techniques to inform laboratory activities.
Maintain accurate laboratory records and ensure compliance with safety and quality standards

Essential Skills & Experience

Bachelors degree in biological sciences or other related scientific subjects
Minimum 3+ years’ experience in designing and implementing, PCR/NGS and or ELISA experiments
Strong understanding of assay verification and validation in line with regulatory standards such as IVDR and CLSI
Experience working within a regulated laboratory environment (ISO17025/ ISO15189 / CAPCLIA)
Excellent interpersonal skills and presentation skills
Excellent problem-solving skills and the ability to work independently as well as part of a team
Able to work flexibly as required to ensure business needs are met.
Proof of Right-to-Work in the UK.
Must be able to commute daily to Belfast as job is 100% on-site.

Desirable Skills & Experience

MSC/PhD in biological sciences or other related scientific subjects
Previous experience in a commercial laboratory
Experience in IHC/histology
Prior experience working in a rapid growth, SME environment
Experience with IVDR/IDE regulation
HEP B Vaccinated (willingness to be vaccinated at start of role)

ARC Regulatory is an equal opportunities employer and is committed to fostering an inclusive and diverse work environment where all employees feel valued, respected and empowered to succeed. We welcome applicants from all backgrounds, genders and experiences to apply for all active roles within our company.