Reagent Manufacturing Shift Team Leader
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 may be based at either our site in Stirling or in Eurocentral and requires 24/7 shift work
We are currently recruiting for a Reagent Manufacturing Shift Team Leader to work within our reagent manufacturing department. You will manage a shift team of technicians and scientists in a GMP environment responsible for manufacture of reagents for commercial sale and related validation activities. Manufactured reagents will be used to produce test strip devices for a wide range of assays on the LumiraDx platform. You will be responsible for Reagent Manufacturing Scientists and Analytical Scientists on a designated shift and will report into the Reagent Manufacturing Manager.
- Plan and schedule all resources for reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements on the shift.
- Provide ‘voice of customer’ input and work in conjunction with R&D to drive transfer of scalable, robust processes and test methods into manufacture which will meet all reagent and strip production needs.
- Facilitate purchase of suitable equipment for the manufacture and testing of reagents including the creation of related documentation, service contracts and validation activities required for use.
- Ensure timely upload of real time material and labour data into ERP system
- Support FMEA and H&S risk assessment activity, to ensure all risks to product and people associated with reagent manufacture are sufficiently mitigated/controlled.
- Ensure the reagent manufacturing processes and associated testing on shift are carried out safely and efficiently.
- Provide input to validation plans for equipment, processes and test methods for the department.
- Design, execute and analyse appropriate experiments for assessing and improving batch to batch performance and reagent manufacturing operations in general.
- Coordinate creation and appropriate review of Manufacturing SOPs, WIs and batch records
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and people development, along with the following experience:
- Experience of validation activities and operating within a GLP manufacturing laboratory environment.
- Line management experience
- Detailed knowledge and experience of high volume, commercial immunoassay (or similar) manufacture and testing.
- Good at troubleshooting and identifying and implementing control procedures and process improvements
- Computer literacy, data analysis interpretation skills and good attention to detail
- Effective communicator and motivator - good people development skills
- Ability to work 12 hour shifts to support 24/7 manufacture
- Experience of working with particle-based immunoassays and knowledge of the particle functionalisation chemistries.
- Experience of working in the medical device sector.
- Experience in statistical analysis techniques
- Degree level qualified, or equivalent, in a science subject
- Six Sigma Green Belt or Black Belt Qualification
- Knowledge and experience of working within a biohazard environment.
- Working knowledge of electrochemical, fluorescent and particle analysis methods (including Flow Cytometry and Dynamic Light Scattering).
For further information and to apply for this role, please click APPLY