Reagent Manufacturing Manager
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 will be working days - Monday to Friday 08:30 to 17:30.
We are currently recruiting for a Reagent Manufacturing Manager to lead our reagent manufacturing department. You will be responsible for ensuring delivery of consistently high quality assay reagents through the management of day to day activities and performance of the reagent manufacturing team as well as the validation and implementation of new processes and test methods into the department.
- Provide ‘voice of customer’ input to R&D to drive delivery of scalable, robust processes and test methods which will meet all reagent and strip production needs.
- Purchase suitable equipment for the manufacture and testing of reagents.
- Support FMEA and H&S risk assessment activity, to ensure all risks to product and people associated with reagent manufacture are sufficiently mitigated/controlled.
- Create and deliver of validation plans for equipment, processes and test methods for the department.
- Plan and schedule all resources for reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements.
- Ensure the reagent manufacturing processes and associated testing are carried out safely and efficiently.
- Create robust and practical Manufacturing SOPs, WIs and batch records and maintain all supporting documentation for the department.
- Design, execute and analyse appropriate experiments for assessing and improving batch to batch performance and reagent manufacturing operations in general.
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:
- Degree level qualified in a science subject.
- 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.
- Able to write and execute clear and concise protocols for complex reagent manufacturing procedures
- Computer literacy, data analysis 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.
- Working knowledge of electrochemical, fluorescent and particle analysis methods (including Flow Cytometry and Dynamic Light Scattering).
- Experience of working in the medical device sector.
- Knowledge and experience of working within a biohazard environment.
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable 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. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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