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 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
- 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
- Degree qualified in a relevant scientific discipline or equivalent relevant industry experience.
- Line management experience.
- Experience of validation activities and operating within a GLP manufacturing laboratory environment.
- Detailed knowledge and experience of high volume, commercial immunoassay manufacture and testing.
- Good at troubleshooting and identifying and implementing control procedures and process improvements.
- Computer literacy and data analysis 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.
- Working knowledge of electrochemical, fluorescent and particle analysis methods (including Flow Cytometry and Dynamic Light Scattering).
- Experience of working in the medical device sector.
- Six Sigma Green Belt or Black Belt Qualification.
- Experience in statistical analysis techniques.
- Knowledge and experience of working within a biohazard environment.
For further information and to apply for this role, please click APPLY