Senior Scientist Reagents
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 key reagent activities to optimise performance such as:
- Coupling chemistries used in preparation of antibody coated microparticles.
- Coupling chemistries used in preparation of fluorophore labelled conjugates.
- Lead the development of scaleable reagents processes and facilitate transfer to manufacturing.
- Lead the design, development and qualification of in process tests to track and trend performance of assay reagents.
- Design, execution and analysis, using statistical tools, of appropriate experiments for the purpose of assessing and improving assay reagents.
- Ensure that the developed reagents are tested to demonstrate they meet the required performance, stability and cost requirements for the assay platform incorporating Voice of Customer and Design for Manufacturing.
- Solve problems encountered during reagent and assay development innovatively and independently.
- Writing and communicating technical updates within the team and across the organisation.
- Ensure Design Control procedures are adhered to and that required reports and procedures are written.
- Input into validation and verification activities.
- Create and maintain quality records for the purpose of assessing and improving assay methodologies and documenting experiments.
- Ensuring you are trained on all appropriate procedures and training new personnel if and when required.
- Technically reviewing change controls and peer reviewing laboratory note books.
- Manage and develop scientists and technicians within the team.
- Plan and prioritise bodies of work to meet project deadlines taking into account the needs of multiple customers.
- Work according to GLP and Design Control.
- Collaborate within a one team ethos throughout R&D, scale up and transfer and manufacturing.
- Degree qualified in a relevant scientific discipline.
- Line management experience.
- Experience in protein and surface chemistry processes, protein to protein coupling, and protein to surface coupling.
- Experience and understanding of characterisation techniques used to assess performance of antibody conjugates and microparticles.
- Protein purification and analysis.
- Experience in the use of particle characterisation techniques e.g. flow cytometry, zeta sizer.
- Experience in the use of HPLC and FPLC (AKTA).
- Experience working in an IVD regulated environment,.
- Developing reagents as part of commercially launched products through CE marking or 510k regulatory pathways.
- Working knowledge of electrochemical and fluorescent methods.
- Experience and understanding of optimisation of reagent stability, assay performance and batch to batch variability.
- Experience and understanding of factors important in drying reagents for use in immunoassays.
- Experience in process scale up and characterization.
For further information and to apply for this role, please click APPLY