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 OEM’s.
We focus on the disposable component of diagnostic tests and have significant expertise with point of care (POC) in vitro diagnostics (IVD). We can provide full assay development services and have impressive in-house manufacturing capabilities, ranging from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.
Our modern facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow. Further growth means that we are now expanding our operations capabilities and have a requirement for a talented and experienced Production Development Scientist. With a healthy mixture of UK and international clients, we are a forward-looking organisation with an exciting future.
As a qualified scientist you will bring hands-on, technical expertise to the company. Having gained experience in the laboratory, you will understand in-vitro diagnostics and may have some specific experience in reagent development and common assay detection methods.
As a contract business, we work on multiple projects simultaneously. This brings a lot of variety and requires people who are both willing and able to develop new products and processes in unison with our design control process. Working for a start-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.
Your time will be spent working on some of our customer specific contracts (developing and producing diagnostic products on their behalf) and working on internal development programmes.
Reporting to the Product Development Technical Lead, you will: –
- Build reagents / formulate customer solutions to their requirements
- Develop and execute electrochemical and reagent experiments for external customer requirements, and internal development programs
- Develop reagent deposition methods, and sensor build processes to ensure rapid, consistent, and precise sensor production for development programs
- Manage on-site chemicals / reagents with regards to inventory, H&S, storage, and containment
- Execute R&D protocols and reports, ensuring compliance with the documentation requirements withing the GLP lab
- 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
- Produce characterization reports for customer products and development reports for internal programmes aligned to FMS design Quality Management System
- Stay informed with regards to current trends and methods in IVD development through routine review of current scientific literature
Essential Technical Skills
You will: –
- Be competent using routine laboratory equipment
- Experienced in building reagents and formulations from first principles
- Have experience in electrochemical methods or other IVD detection systems
- Have experience in IVD product development
- Be competent using complex laboratory equipment such as reagent deposition systems and contact angle measurement equipment
- Be able to process raw data and summarize findings effectively
- Understand Good Manufacturing and Good Laboratory Practices requirements (GxP)
- Have worked to ISO13485 and 21 CFR Part 820 and will be familiar with design control and product & process validation
Desirable Technical Skills
It would be beneficial if you: –
- Have competency in the use of modern manufacturing equipment (e.g. lasers, dispensing, lamination & assembly) and metrology equipment such as CMM
- Understand Design for Manufacture (DFM) methodology
- Experienced using statistical tools such as Minitab, and understands Design of Experiments methods (DoE)
- Experienced in reagent chemistry as applied in IVD products
- Experienced in surface chemistry: modification and analysis
- Experience in microfluidic devices
Knowledge & Experience
- You will hold a degree in a relevant scientific subject as a minimum and have at least 3 years relevant experience in a regulated environment. However, consideration will be given where relevant academic experience can be demonstrated in lieu of industry experience
- A green or black belt qualification in six sigma / process excellence would be advantageous but is not a pre-requisite
- People management experience would be advantageous but is not a pre-requisite
Environment & Culture
FlexMedical Solutions is an evolving, scaling organisation operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of leading edge projects with some very 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 colleagues and contribute to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a lot of variety and excitement. Initiative will be rewarded, and personal development is a given.