Job Title: Senior R&D Scientist Reporting To: Laboratory Manager Location: Belfast Hours: 39 hours/week 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 support client demand, ARC has recently opened a new laboratory facility, enabling the company to offer an end-to-end service to its client base. 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 utilization of regulated experimental approaches to clinical studies, as well as an innate work ethic that aligns with the companys core values. Key Responsibilities: The Senior R&D Scientist is expected to: Lead in the development, optimisation, and validation of assay protocols for a range of assays - primarily ELISA but may also include IHC and PCR-based assays. 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. Review data and reports of laboratory scientists. 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. Support the Laboratory Manager in the mentorship of junior scientists whilst ensuring that laboratory-related activities are conducted in accordance with approved protocols and processes. Essential Criteria Minimum Masters degree (or equivalent) in Biological Sciences or other related scientific subject. Minimum 3 years experience in Pharmaceutical/commercial or clinical testing laboratories. Experience in working under design control/regulated product design (ISO13485). Strong understanding of ELISA assay development and validation for single and multiplex targets. Experience in the drafting and review of assay validation/ test scope protocols and reports. Excellent problem-solving skills and the ability to work independently as well as part of a team. Desirable Criteria PhD in Biological Sciences or other related scientific subject. Experience of working in compliance with ISO17025, CAP CLIA and IDE regulation. Practical experience with standard laboratory techniques, including IHC and PCR. Strong communication and presentation skills; comfortable delivering training and providing key laboratory updates to a cross-functional team. Please Note: This a 100% onsite position within ARCs Laboratories, based in Belfasts Titanic Quarter. This role will involve working with human biological samples and therefore, the company recommends that employees have appropriate vaccinations (eg: Hepatitis B) the company will support this if needed. Benefits Onsite parking Private Medical insurance Attractive Salary and Annual Leave allowance Employee Referral Scheme Skills: Laboratory IVDR Benefits: ONSITE CAR PARKING PRIVATE MEDICAL ATTRACTIVE SALARY EMPLOYEE REFERRAL