Reagent Manufacturing 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 450 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
Responsible for supporting the validation of new processes and methods and performing the ongoing reagent manufacture and testing, to ensure the supply of consistently high quality assay reagents to production.
- Provide feedback and evaluation support to R&D to aid delivery of suitably robust processes and test methods.
- Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of reagents.
- Ensure raw material and consumable availability and prepare process buffers and stock solutions, to allow reagent manufacturing schedule to be met.
- Manufacture assay reagents safely, efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
- Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
- Carry out routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Support the design, execution and analysis of experiments for improving reagent manufacturing operations.
- Adhere to all relevant regulatory GLP, GMP and GDP requirements.
- Assist with the creation and update of SOPs/WIs as required.
- Create and update COSHH assessments and follow and comply with all relevant internal quality and H&S processes and procedures.
- Raise non-conformances and lead investigations and corrective actions.
- Accurately complete batch records and reports, recording and communicating all process observations and deviations.
- Be familiar with business goals, and work with colleagues in delivery of individual and team goals.
- Undertake own training and support development of team members where required.
- Communicate effectively within own team and with other departments and external contacts as required.
- Degree level qualified, or equivalent, in a science subject
- Experience working within a GLP manufacturing laboratory environment and confidence to work without supervision
- Ability to follow complex protocols and accurately complete batch records
- Computer literacy, data analysis interpretation skills and good attention to detail
- 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
- Experience of working within a biohazard environment
- Commercial diagnostic assay experience
- Experience in statistical analysis techniques
- Six Sigma Green Belt or Black Belt Qualification
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