R&D Scientist

ABOUT LGC CLINICAL DIAGNOSTICS:

LGC Clinical Diagnostics 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, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. 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 Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

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.

Are you ready to make a significant impact in the field of life sciences? At LGC, we are searching for a dedicated R&D Scientist to join our dynamic team in Tipperary, Ireland. This outstanding opportunity allows you to be at the forefront of groundbreaking research and development, contributing to our mission of delivering flawless diagnostic solutions!

Responsibilities

• Drive new product development, specifically in control and calibrator product research, development, and manufacture.
• Seamlessly integrate the build and development process within product development, adhering strictly to ISO13485 standards.
• Incorporate comprehensive risk analysis activities in alignment with ISO14971, ensuring world-class safety and efficacy.
• Lead Product Improvement and Build Change Projects with a focus on innovation and excellence.
• Build and lead all aspects of verification test protocols, coordinating evaluation and application studies for new or existing IVD products on specified clinical systems.
• Standardize proteins and assign serum protein values from reference preparations to target materials with precision.
• Conduct detailed evaluation studies for new or existing Multichem products on specified clinical systems, carefully detailing test results.
• Analyze technical data, generating robust technical reports and change management documentation that ensure defendable practices and conclusions.
• Develop comprehensive outputs for completed projects such as SOPs, specifications (product and quality control), for new builds or improvements to existing products.

Requirements

• Degree qualification in a relevant Science or Engineering field or equivalent experience.
• A minimum of 3 years of industry experience in a regulated medical device/manufacturing area or equivalent.
• Proven knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC, and international regulatory requirements.
• Strong familiarity with statistical evaluation techniques.
• Outstanding interpersonal abilities with the capacity to communicate clearly both orally and in writing.
• Outstanding attention to detail and the capability to prioritize tasks efficiently.

Join us at LGC, where your expertise will be valued, and your career will thrive as we work together to achieve our ambitious goals. Your contribution will be vital in successfully implementing our innovative solutions and competing in the global market.

ABOUT LGC:

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.

OUR VALUES

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website www.lgcgroup.com

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