Reagent Manufacturing Shift Team Leader
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Bullet points
Exciting Opportunity
Excellent career potential
About Our Client
Our client, 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.
They are a dynamic, high growth organisation with a team of talented, passionate and creative people. We are partnering exclusively with them to recruit across the business as they grow to meet increased demand in these unprecedented times. We are looking for proactive, experienced, hard working and enthusiastic individuals who can make a significant contribution to the continued growth and success of this dynamic and forward-looking company.
LumiraDx is rapidly expanding and currently has over 1,200 employees worldwide
Job Description
We are currently recruiting for a Reagent Manufacturing Shift Team Leader to work within LumiraDx's 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.
Key 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
The Successful Applicant
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:
Essential Skills:
- 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
- The shifts are - 4 on 4 off working 2 days then 2 nights (7 till 7)
Desirable 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).
What's on Offer
Excellent salary plus 35% shift allowance and great benefits package (including free employee COVID testing on site).
Please note, if you wish to submit an application for this role, please consider the following information:
PageGroup are our exclusive recruitment partner for this vacancy and all applications, whether internal or external, will be forwarded to them.
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 client's 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.]