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