Senior R&D Scientist

Our client operate in the Medical Devices space and focus on the design, development, and manufacturing of point-of-care (POC) diagnostic devices and wearable biosensors. They are currently looking for a Senior R&D Scientist to join their team on a permanent basis. The role is based in Livingston.

As a significantly experienced scientist you will bring hands-on technical, and strategic expertise to the company.

Having demonstrated superior skill in the lab through multiple programmes, you will be skilled in the development of in-vitro diagnostics and will have specific experience in reagent development for common assay detection methods such as e-chem, fluorescence, chemiluminescence. You will be engaged in customer specific contracts, developing and producing diagnostic products on their behalf, in addition to internal development activity.

As a contract business, we work on numerous projects with several clients simultaneously. This brings a lot of variety and requires people who are both willing and capable of working on concurrent multiple projects.

Working for a scaling organisation will provide you with a fantastic opportunity to make your mark and implement your ideas, helping to steer the company’s technical direction.

Key Responsibilities

Reporting to the Technical Lead/CTO, you will: –

• Manage significant bodies of work within major projects, and / or manage complete minor projects and all associated client relationships and design control responsibility.
• Design and build reagents necessary to facilitate biochemical reactions as part of an IVD development.
• Develop and execute electrochemical testing experiments, aligned to the needs of the projects.
• Translate wet chemistry design and performance to dry chemistry formats to ensure retention of performance and reliability of low cost biosensors for a range of sample types.
• Write and execute R&D protocols and where necessary verification protocols.
• Execute and report lab experiments in support of external client projects and internal development programmes.
• Provide scientific input into product and process designs ensuring optimal performance and client satisfaction.
• Supervise and mentor less experienced members of the technical team, ensuring their work meets quality expectations and is aligned to project critical paths.
• Lead by example technically and non-technically, especially within the lab, and ensure company values are upheld.
• Prepare and supply reports to internal and external stakeholders.
• Independently and rapidly root cause and robustly resolve technical challenges within projects to maintain timelines.
• Transfer technical design and processes into routine manufacturing.
• Produce characterisation reports for customer products and development reports for internal programmes
• Stay informed of latest developments and trends in your field e.g. current trends and methods in IVD development through routine review of current scientific literature.
• For larger projects, you may also be required to manage and develop others.

Skills, Knowledge and Experience

Essential

• As a minimum, you will hold a degree level qualification in a relevant scientific subject (in lieu of academic qualification, we will consider candidates with significant similar industry experience)
• Significant, demonstrable, relevant experience gained in a regulated environment
• Experienced in designing and building biochemical reagents and formulations from first principles
• Experienced in electrochemical methods and other complex IVD detection formats
• Experienced in rapid prototyping of novel biosensors or IVDs
• Experienced in protein chemistry and / or surface chemistry and analysis
• Experienced in IVD product development in a commercial setting
• Competent using complex laboratory equipment such as Spectrophotometers, potentiostats, and HPLC/FPLC systems
• Able to process raw data and summarize findings effectively to drive complex decision making necessary optimise IVD design
• Understand and exercise Good Laboratory and Good Manufacturing Practices (GxP)
• Experienced working to ISO13485 and / or 21 CFR Part 820, and familiar with design control and product & process validation
• Experienced in planning complex bodies of work and effectively working to planned timescales, communicating the plan, and tracking progress.

Desirable

• A Green or Black Belt qualification in Six Sigma / process excellence
• Competent in the use of modern manufacturing equipment e.g. lasers, dispensing, lamination & assembly
• Understand Design for Manufacture (DFM) methodology and have experience in implementation
• Experienced in using statistical tools such as Minitab and understand Design of Experiments methods (DoE)
• Experienced in optimisation of screen printed electrodes for biosensor applications
• Project Management experience
• People management experience.

Apply above or reach out to me at ak@kleboejardine.com for a confidential discussion about the opportunity