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 currently has over 700 employees worldwide. 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