Our client is an innovative Scottish SME that provides contract design, development and manufacturing services to medical device OEM’s.
The business is seeking an experienced Senior Scientist to bring hands-on, technical expertise to the team specialising in the development of IVD. The role will have a key focus on assay detection methods and work on multiple projects with several clients simultaneously providing variety and technical challenge.
Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf), and also working on internal development programmes.
You will be an active contributor in the company and benefit from exposure to make your mark and implement your ideas to help steer the company’s technical direction.
Reporting to the CSO, you will: –
- Manage significant and discrete bodies of work within projects, major and minor.
- 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 clients’ programs.
- Translate wet chemistry design and performance to dry chemistry formats to ensure retention of performance and reliability of a 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 projects’ critical paths.
- Lead by example in the lab technically and non-technically, ensuring company values are upheld within the teams.
- Independently and rapidly root cause, and robustly resolve technical challenges within projects.
- Transfer technical design and process into routine manufacturing.
Knowledge, Skills & Experience
Essential Technical Skills
You will: –
- Be experienced in designing and building biochemical reagents and formulations from first principles.
- Have experience in IVD product development in a commercial setting.
- Be competent using complex laboratory equipment such as Spectrophotometers, potentiostats, and HPLC/FPLC.
- Understand Good Manufacturing and Good Laboratory Practices requirements (GxP)
- Be experienced with ISO13485 and/or 21 CFR Part 820 and familiar with design control and product & process validation.