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. 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 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 #scienceforasaferworld