Reagent Manufacturing 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
We are currently recruiting for a Reagent Manufacturing Team Leader to work within our reagent manufacturing department. You will manage a team of technicians and scientists in a GMP environment responsible for the validation and transfer of new process and test methods from development into the manufacturing department. You will also provide support where required to manufacture and test reagents for commercial sale and related validation activities. You will be required to collaborate with the manufacturing shifts as well as the development transfer team.
- Plan and schedule all resources for validation activities as well as reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements.
- 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.
- Ensure creation of appropriate validation documentation and protocols in collaboration with supporting departments, in particular QA and Product Assurance
- 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 new raw material and consumable availability for newly introduced processes and 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 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
- 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