LGC’s Clinical Diagnostics Business Unit develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Technopath Clinical Diagnostics, which is highly regarded as a leader in the IVD industry, having developed a first-of-its-kind range of consolidated immunochemistry quality control products, The Native Antigen Company, which is a manufacturer and supplier of antigens and antibodies, which are key components in vaccine research, and for the accurate diagnosis of a wide range of infectious diseases, SeraCare Life Sciences and Maine Standards, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials). Our 450+ employees operate an ISO 9001-accredited facility in Tipperary (Ireland), Oxford (UK), and FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA.

Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

The successful candidate will be able to demonstrate the following behaviours in line with LGC’s Core Values:

• Passion: Pride in our achievements engenders passion for our work and it translates into our ambition to make the world a safer place.
• Curiosity: We constantly look forward to what's next: our curiosity for today's discoveries makes tomorrow's innovations possible.
• Integrity: A commitment to high ethical standards has been at the heart of LGC since we started testing the integrity of products in 1842.
• Brilliance: We strive to be the very best in everything we say and do. We exceed customers' expectations through innovation and pioneering science.
• Respect: We respect gender, age, nationality, religion and individuality – our diversity is our strength.

Role and Responsibilities:

• Full responsibility for operational activities including manufacturing, warehousing and supply chain.
• Establish, monitor and achieve performance criteria, targets, budgets and KPIs (annual, quarterly, monthly, weekly & daily).
• Ensure the highest standards of product quality are achieved and constantly improved upon.
• Set and manage standards for all functions to ensure coordinated efforts to achieve optimum results
• Continue to drive operational improvements to enhance production effectiveness and optimise the use of limited resources.
• Develop and implement an updated long range site plan.
• Ensure compliance with relevant regulatory and legal requirements
• Responsible for establishing and maintaining excellent vendor/supplier relationships
• Plan, structure and adequately resource the team to meet business requirements
• Provide leadership: direction, coaching and development of team
• Develop and manage relationships with customers and key external audiences
• Responsible for working with QA/RA department in efficiently transferring the QC lab to operations
• Work closely with the other departmental leads in building and scaling teams and systems
• Performs other related duties as assigned by manager.

Qualifications:

• Science qualification and/or strong IVD industry experience.
• Minimum of 10 years of IVD manufacturing or relevant life science operational experience.
• Strong interpersonal skills and the ability to communicate well both verbally and in writing.
• Strong problem solving skills combined with logical and clear thinking.
• Customer orientation and focus.
• Ability to develop relationships and manage expectations externally.
• Deep understanding of quality environment and general knowledge of regulatory environment.
• Ability to work in a dynamic and fast moving environment.
• Excellent attention to detail and ability to prioritise.

Other Skills Required:

• Budgeting and Financial Management skills.
• Team management, Building, Mentoring and Development.
• Project management skills.
• Ethical
• Team player who fosters goodwill and respect in the immediate and greater team environment.