Technical Manager 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 is a permanent role and you could be based at either at our site in Stirling or Glasgow.
Due to growth we are recruiting a Technical Manager in Assay Development where you will lead a project team to develop and deliver diagnostic assays to meet the product requirements for launch in line with the company’s goals and timelines. You will also be responsible for the technical leadership of the project as well as the continuous growth and development of the projects scientific team.
Key roles and Responsibilities:
- Leading the development of individual assays from concept through Design Freeze and Transfer to Production to Launch following our Design and Development process incorporating Design for Manufacture(DFM) approach.
- Run the daily cross functional project meetings incorporating Voice of Customer.
- Create and communicate project updates to all levels of the business.
- Ensure key suppliers are managed and generate critical to quality specifications and appropriate validated test procedures.
- Managing internal and external partners to support the assay development.
- Developing a robust assay system through product characterisation, risk management and testing to failure.
- Ensuring that the developed assay and its components are capable of meeting the required performance, stability and cost requirements for the assay platform.
- Ensuring Design Control procedures are adhered to and generate project deliverables such as:
- Design & Development Plans
- Product Requirement Documents
- Design History Summary report
- Pre Validation and Verification Plan
- Ensuring GDP, GLP and GMP standards are maintained.
- Managing and developing teams of up to twelve technical staff ensuring that each team member’s role, tasks and time lines for delivery are clearly defined and communicated.
- Ensure individuals within the team are motivated and developed to reach their potential
- Degree qualified in a relevant scientific discipline
- Technical and team leadership skills - ability to lead by example and develop the skills and competency of the project team
- Able to motivate self and others, with a flexible, can-do attitude
- Project planning and management skills
- Detailed knowledge and understanding of factors which drive Immunoassay performance (such as stability, precision, sensitivity, accuracy)
- Experienced in root cause analysis and technical problem solving.
- Experience of working to ISO 13485 or FDA 21CFR, part 820 (or similar)
- Experience and knowledge of requirements to launch an in-vitro diagnostic product (validation and verification, FMEA, control solutions, on-board controls, )
- Experience of leading multiple R&D projects, from proof of concept to product launch.
- Experience of leading technical and project teams of varying sizes
- Experience of using particle-based immunoassays.
- Experience with fluorescent technology
- Experience of optimising formulations for drying reagents for use in POC immunoassays
- Experience with launching IVD products in multiple geographies (US, OUS, China)
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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