Company Overview
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.
Role Description
As a recently qualified scientist you will bring technical expertise to the company. With undergraduate experience in the laboratory, you may already have some understanding of in-vitro diagnostics and may have some specific knowledge in electrochemical and other common assay detection methods.
You will have an interest in how products work chemically, mechanically, and electrically. As such, will spend time in other areas, namely operations and engineering, developing your knowledge of our processes and business.
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. Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf) and working on internal development programmes.
Working for a scaling organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.
Key Responsibilities
Reporting to the Technical Lead or R&D Senior Scientist, you will: –
- Build reagents / formulate customer solutions to their requirements
- Execute electrochemical methods for external customer requirements, and internal development programmes
- Perform tasks on FMS dispensing systems to accurately deposit solutions and perform subsequent gravimetric analysis
- Manage all on-site chemicals / reagents with regards to inventory, H&S, storage, and containment
- Execute protocols and summarise the outcome in formal reports
- Execute and report lab experiments in support of external client projects and internal development programmes
- Document project work in a compliant manner and in line with the FMS quality management system
- Provide scientific input into product and process designs ensuring optimal performance and client satisfaction
- Initiate non-conformance reports as and when required
- Support routine product manufacturing where required.
Skills, Knowledge and Experience required
Essential
- A degree in a relevant scientific subject
- Competent using routine laboratory equipment
- Some experience in building reagents and formulations from first principles (buffers)
- Able to summarise and perform basic statistical analysis on data
- Able to record data and report outcomes in a compliant manner
Desirable
- Work experience in a regulated environment (such as IVD)
- A keen interest in IVD products and their development
- A keen interest in electrochemical methods and other IVD detection systems such as fluorescence. chemiluminescence, optical lateral flow devices
- Knowledge of protein conjugation and purification
- Organic chemistry understanding
- Understand Good Manufacturing and Good Laboratory Practices (GxP)
- Understand Design for Manufacture (DFM) methodology
- Understand Design of Experiments methods
- Experience of using statistical tools such as Minitab
Environment & Culture
FlexMedical Solutions is a young, evolving and 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 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.