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Lead Specialist
3 months ago
Job Summary
We provide diagnostic reagent products to blood transfusion services and hospitals in the UK, EU and wider customer base, providing ca , bottles of product per year. In this role you would play a critical role, as a subject matter expert, and lead on service and product development implementing a range of change programmes or projects addressing standardisation, new ways of working, introduction of new technology, service and product development and improved performance.
We have an ambitious strategy to align to the changing regulatory environment whilst delivering on new product developments with an aim to improve patient care, quality of products and value for money.
You will be a core member of the team driving these projects in our specialist reagents departments and our specialist diagnostic laboratories. You will own a number of process and product development lifecycles from the discovery phase through analysis, adoption, development, implementation and post implementation monitoring, delivering projects on time and to budget, operating independently but with support and guidance.
Main duties of the job
In this role, you will act as a subject matter expert, leading on service and product development within Pathology with an initial focus on Reagents. Your duties include:
Supporting and evaluating, innovative ideas that contribute to the development of strategy and improved service delivery. Leading on and implementing a range of change programmes or projects addressing standardisation, new ways of working, introduction of new technology, service development, product development and improved performance. Providing expert advice on standards and specifications for systems, processes, consumables, and equipment and leading on evaluation and procurement processes. Developing expertise and providing the primary point of contact for all stakeholders within a designated area and supporting the operation in the maintenance of quality. Maintaining a thorough working knowledge of practices, procurement, licensing, and regulatory requirements (IVDR, UK MDR, ISO) in all areas associated within Pathology and in particular relating to design, development, manufacture and testing of NHSBT produced reagents. Having expert knowledge in in-vitro diagnostics processes, products and regulations, and deputising for Head of Department as required.You will be required to travel and spend time away from base, which will involve working irregular hours and overnight stays when required, with prior notice.
About You
Experience and Knowledge
Advanced level of knowledge of transfusion science gained through working in a transfusion laboratory or education establishment. Developed scientific and technical knowledge and understanding of in-vitro diagnostic processes, and well informed regarding new developments. Thorough understanding of Good Manufacturing Practice, Good Laboratory Practice, Operational Improvement and Total Quality Management. Expert knowledge in in-vitro diagnostics processes products and regulations Experience of setting objectives for direct reports and undertaking performance reviews. Experience in risk management, process qualification and change control. Knowledge of change management and service redesign. Experienced in managing projects and delivering change. Experience of working with Information Technology using Microsoft Office packages (Word, Excel and PowerPoint).Qualifications and Training
Masters level qualification or equivalent relevant professional qualifications or demonstrable knowledge and experience to Masters level. Demonstrates commitment to own continued professional development (CPD).