Senior Verification Scientist
Manor Loan, Stirling
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
- Lead the development of significant project activities which may include;
- Taking responsibility for the verification testing for an assay or version of the LumiraDx instrument.
- Developing or improving new departmental processes.
- Planning and executing appropriate experiments for the purpose of developing verification testing methods and assessing assay performance in line with design inputs.
- Overseeing clinical sample testing for the department
- Use statistical methods to design and analyse experiments and make the appropriate scientific conclusions and define next steps required.
- Solve problems encountered during assay development innovatively and independently.
- Create and maintain quality records for the purpose of assessing and improving assay methodologies and documenting experiments in line with the requirements of the LumiraDx quality management system
- Technically reviewing change controls and peer reviewing laboratory notebooks.
- Raising, investigating and closing non-conformances to agreed timelines.
- Completing COSHH assessments as and when required.
- Ensuring you are trained on all appropriate procedures and training new personnel if and when required.
- Ensuring you work in conjunction with the quality policy and objectives.
- Help less experienced members of the verification team to carry out experiments effectively.
- Writing and updating lab and project related procedures and documents.
- Lead cross functional engagement in solving complex problems encountered during product development.
- Managing and developing a team of up to five technical staff within the Verification department.
We are looking for an experienced Verification Scientist with the following attributes:
- Line management experience.
- Degree in a relevant scientific discipline
- Track record of Verification and Validation testing for In Vitro Diagnostics or Medical Devices or similar regulated industry
- Knowledge of product and process validation and verification.
- Knowledge and understanding of factors which drive assay performance
- High levels of skills in problem solving and innovation
- Strong organisational skills
- Ability to write clear and concise protocols for complex verification testing
For further information and to apply for this role, please click APPLY