At FlexMedical Solutions (FMS), we help our customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEMs. Our main focus is on Point of Care (POC) in vitro diagnostic (IVD) tests.
We focus on the disposable component of the device and have significant expertise with point of care (POC) in vitro diagnostic (IVD) tests. Our in-house capabilities range from screen printing and laser ablation of electrodes for biosensors to final device assembly, including controlled deposition of chemistries.
Established in 2015, we have continued to expand our facility to a very high standard and have successfully helped several of our clients design, develop and commercialise their products. We are now entering the next phase of our growth, as we embark on volume production.
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).
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 multiple projects simultaneously. Your time will be spent engaged on customer specific contracts (developing and producing diagnostic products on their behalf) in addition to internal development activity.
Working for a scale-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas, helping to steer the company’s technical direction.
Reporting to the Technical Lead, 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 is of acceptable quality and aligned to project critical paths.
- Lead by example in the lab technically and non-technically, ensuring company values are upheld within the lab.
- 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 aligned to FMS’s Quality Management System.
- 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.
Skills, Knowledge and Experience required
- As a minimum, you will hold a degree level qualification in a relevant scientific subject.
- Significant, demonstrable, relevant experience gained in a regulated environment.However, consideration will be given where relevant academic experience can be demonstrated in lieu of industry experience.
- Experienced in designing and building biochemical reagents and formulations from first principles.
- Experienced in electrochemical methods or other complex IVD detection architectures.
- 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 optimize IVD design.
- Understand and exercise Good Manufacturing and Good Laboratory Practices requirements (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.
- A Green or Black Belt qualification in Six Sigma / process excellence is highly advantageous.
- 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.
Environment & Culture
FlexMedical Solutions is a young and evolving start up organisation, now scaling, and operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of leading edge projects with exciting customers.
It is a changing environment that requires you to be very flexible and willing to learn and grow with the company. It is essential that you communicate with your team and contribute to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a great deal of variety and excitement; initiative will be rewarded and personal development is a given.