R&D Technical Manager (Reagents)

Location

Manor Loan, Stirling

Job Type

Permanent

Company Overview

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

Opportunity:

We are currently recruiting for a R&D Technical Manager (Reagents) to be a key member of the Reagents Team, responsible for the design & manufacture of high performance immunoassay reagents to achieve successful product launches and high volume manufacturing requirements.  You will lead a project team to develop and deliver novel reagent designs for application in immunoassays to support product launches in line with the company’s goals and timelines.
Key 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

Required Experience

About You:
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and a can do attitude, along with the following experience:
Essential Skills: 
  • 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.
Desirable Skills:
  • 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

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process 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.