Reagent Manufacturing Shift Scientist
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
- Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of reagents.
- Ensure raw material and consumable availability to facilitate required process builds to meet reagent manufacturing schedule.
- Manufacture assay reagents safely, efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
- Evaluate the performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
- Schedule routine calibration, maintenance, and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Management of the day to day activities responsible within the shift, and organisation of workload and team members.
- Responsible for the upload of real-time material and labour data into the ERP system.
- Degree qualified in a relevant scientific discipline.
- Line management experience
- Experience working within a manufacturing laboratory following good lab practices and confidence to work without supervision.
- Ability to create and follow complex protocols and accurately complete batch records.
- Knowledge of in-process testing such as electrochemical, fluorescent and particle analysis methods (e.g. Flow Cytometry, Dynamic Light Scattering).
- Knowledge of GMP standards, including Validation protocols and Non-Conformances.
- Can work well within a group environment.
- Computer literacy and data analysis skills.
- Ability to work 12-hour shifts to support 24/7 manufacture.
- Commercial diagnostic assay experience.
- Six Sigma Green Belt or Black Belt Qualification.
- Experience in statistical analysis techniques.
- Knowledge and experience of working within a biohazard environment.
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