Company Description
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, Sera Care 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.


Job Description

• 
  Job Purpose
  

The R&D Scientist is responsible for the performance and monitoring of the project activities assigned to him/her, integrating the design and development process and associated risk analysis activities and design validation programme where applicable. The R&D Scientist will be responsible for complying with design and development process and design change process, as applicable to new or existing IVD products marketed in Technopath packaging that are manufactured in house or by an external supplier (OEM), for assigned projects.

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  New product development, control and calibrator product research and development and manufacture.
  

• Integration of the design and development process within product development, in accordance with ISO13485.
  

• Integration of the associated risk analysis activities in accordance with ISO14971, where applicable.
  

• Product improvement/Design Change Projects.
  

• Creation of verification test protocols and organisation of the evaluation and application studies relevant to new or existing IVD products, on specified clinical systems.
  

• Protein standardisation and assignment of serum protein values from a reference preparation to the target material.
  

• Performance of the evaluation studies relevant to new or existing Multichem products, on specified clinical systems. Documentation of test results.
  

• Analysis of technical data and generation of technical reports and change management documentation ensuring defendable practices and conclusions.
  

• Generation of outputs for completed projects such as SOPs, specifications (product and quality control), regarding new designs or improvements to existing ones.
  

• Key Responsibilities
  

• Ensure that product development projects and changes to existing products are conducted in compliance with applicable Technopath Quality procedures.
  

• Proficiency and Linearity pool development, production, and assignment of values.
  

• Provide training to R&D Scientists on verification/validation and statistical methods.
  

• Validation of excel templates for use in R&D or other technical data analysis functions when required.
  

• Laboratory maintenance.
  

• Stock control/maintenance in line with department budget plans.
  

• Adherence to Laboratory health and safety requirements. Adherence to quality standards.
  

• R&D Equipment calibration/maintenance.
  

• R&D procedural review and update as required.
  

• Supporting QA in the internal audit programme.
  

• Other duties that may become necessary because of system/process changes within or impacting R&D, as outlined by the R&D Manager.
  

Qualifications

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  Degree qualification in a relevant Science or Engineering discipline
  

• 3+ year’s industry experience working in a regulated medical device/ manufacturing area.
  

• Good knowledge of FDA 21CFR820, ISO 13485, IVDD98/79/EC, and international regulatory requirements
  

• Good knowledge of statistical evaluation techniques
  

• Strong interpersonal skills and the ability to communicate well both verbally and in writing.
  

• Excellent attention to detail and ability to prioritise.
  

Additional Information
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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