R&D Technical Manager (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
- Leading the development of reagent formulations from concept through to assay development following our Design and Development process incorporating Design for Manufacture (DFM) and Voice of Customer approach.
- Participate in the Assay development project meetings to support the customer’s needs.
- 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 reagent development.
- Developing reagent methods with a Design for Manufacturing mindset including robustness testing assay system through product characterisation, risk management and testing to failure.
- Ensuring that the developed reagents 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:
- Reagent Feasibility Reports
- Material Specifications
- Reagent Production procedures
- Reagent Test Method procedures
- Managing and developing teams of up to twelve technical staff ensuring that each team member’s role, tasks and timelines 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 & experience - ability to lead by example and develop the skills and competency of the team
- Able to motivate self and others, with a flexible, can-do attitude
- Project planning and management experience
- Detailed knowledge and understanding of key drivers of Immunoassay performance (e.g. stability, precision, sensitivity, accuracy…)
- Experience of developing immunoassays.
- 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, etc.)
- Experience of leading R&D projects, from proof of concept to product launch.
- Experience with fluorescent technology
- Experience of optimising formulations and chemistry for dry reagents for use in immunoassays
- Detailed knowledge of protein & particle chemistry
For further information and to apply for this role, please click APPLY