HOW WE CARE FOR YOU: At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients’ lives. Competitive Pay Comprehensive Benefits Package Career Advancement Opportunities including Apprenticeship [If applicable] Auto Enrolment pension plan SUMMARY The Research and Development Specialist is responsible for the overall study management of method development, validation and investigational activities, ensuring their effective implementation and completion. The post holder will support and coordinate global laboratory, technical, setup and support teams to drive activities ensuring that they are conducted with scientific rigour, the appropriate level of documentation and to the required timelines. The post holder will provide scientific support to ACM clients as well as the Laboratory Operations, Scientific Affairs, Proposals and Business Development functions. ACM Global Laboratories is a growing international organisation that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people’s lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organisation and influence your professional growth. STATUS: Full Time LOCATION: York, UK DEPARTMENT: Research & Development SCHEDULE: Monday - Friday; Days ATTRIBUTES BSc (or equivalent) or higher in a relevant scientific subject. A minimum of 4 years’ experience within a laboratory environment (clinical laboratory experience strongly preferred). Demonstrable experience as a validation / analytical study manager with responsibilities for validation documentation Experience with clinical testing via relevant methodologies (e.g. ELISA, PBMC isolation, flow cytometry). Regulatory experience: working in a GLP and / or GCP framework with demonstrable experience writing, reviewing and approving quality documentation (e.g. change control, CAPA, quality events). RESPONSIBILITIES Technical. Develop validation plans, validation summary reports, stability summary reports, correlation plans and correlation summary reports to meet regulatory requirements .Provide supporting information in the evaluation of appropriate testing and/or methodology. Liaise with technical staff on feasibility of testing for new study requirements. Provide pricing as needed to Proposals teams. Selection of appropriate test methods; research / identify suppliers of materials and equipment options for new tests to support new opportunities. Facilitate assay development, conduct instrument validations and implement new testing to meet the needs of clinical trials protocols, clients and regulatory requirements. Responsible for assay / panel pre-validation and validation and correlation testing globally. Operational. Perform analytical development and validation work where required. Perform the investigation and corrective action for assay troubleshooting and proficiency testing failures. Assess the impact of manufacturer / vendor communications and complete associated documentation. Provide study management and direction of laboratory teams for the implementation of analytical method validations. Provide supportive information for consultation and technical support to clinical trials clients and operational staff. Responsible for communications (meetings, calls audits etc.) with clients and formulate responses as required. Quality. Ensures all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP) etc Document and ownership of any quality documentation (Note to File, Quality Event, CAPA, deviation, change control etc.) as appropriate within the required timeframes. PHYSICAL REQUIREMENTS: S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer. Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.