Senior Scientist Assay Development
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
This role could be based at our site in Stirling OR Glasgow and travel between sites might be required.
The opportunity will involve you developing multiple diagnostic assays for the LumiraDx platform as part of our assay development team.
As a Senior Scientist within the team you will be responsible for the daily management of a complex significant technical projects and may act as line manager or technical lead for a number of less senior staff.
Within this role you will also be responsible for the technical delivery behind a new product line. You will be focused on building, maintaining and using significant depth of knowledge in a specialised technical area critical to the future direction of the company. You will also be accountable to deliver solutions to complex problems which will move programs forward.
- Lead significant technical project and be responsible for delivery (e.g. responsible for one assay within a project team).
- Lead the technical understanding of the future products that are under research and development.
- Deliver technical solutions to key problems raised during product development.
- Create, develop and undertake new experiments in specialist field.
- Prepare and present results / developments for senior management.
- Provide technical input to the team to assist in reaching solutions.
- Challenge scientific and technical rigour of experiments and experimental design.
- Use statistical methods to design and analyse experiments and make the appropriate scientific conclusions and define next steps required.
- Challenge approach to running of protocols and experiments.
- Understand business goals and set and agree appropriate technical goals within team.
- Manage multiple and complex parts of a technical project at the same time.
- Deliver technical solutions to enhance product development.
- Provide day-to-day direction for experiments and project plans of team in line with overall business goals and budget.
- Ensuring Design Control procedures are adhered and that reports and procedures are written.
- Lead and set the standard by which others should follow.
- Create a working environment which acknowledges and pro-actively supports compliance aspects.
- Ensure best practice standards are adhered to. Monitor GLP compliance across relevant areas.
- Approve protocols and develop / enhance processes and procedures.
- Degree Qualified in a relevant scientific discipline.
- Experience and understanding of factors which drive assay performance (including sensitivity, range, stability, reproducibility and precision).
- Skills in problem solving and innovation.
- Experienced in immunoassay technology, and its application within IVD.
- Knowledge of fluorescent detection and other assay detection architectures.
- Track record of developing assays within a design controlled framework.
- Ability to write clear and concise protocols for complex assay methodologies.
- Ability to identify and investigate non-conformances swiftly, and implement robust corrective actions.
- Experienced in summarizing and communicating project data for senior staff and stakeholders.
- Experience of Statistical analysis and Design of Experiments.
- Ensure laboratory books and other records are completed accurately and timely.
- Experience of working in a laboratory within GLP + GDP guidelines.
- Computer literacy and data analysis skills.
- Experience of using particle-based immunoassays.
- Knowledge of reagent/conjugation chemistry.
- Knowledge of validation and verification planning and testing.
- Experience in Design of Experiment and application to product development.
- Experience of GMP / GLP / GDP standards.
- Experience and understanding of factors important in reagent preparation and drying for use in POC immunoassays.
- Experience working in the IVD industry, and having launched IVD products.
- CE marking IVD products, 510K submission and approval process.
- Application of 6-Sigma within an R&D setting.
- Knowledge and experience of working within a biohazard environment.
- Line managment experience.
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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