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 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 Scientist to work within our reagent manufacturing department. You will work within a team of technicians and scientists in a GMP environment to facilitate 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 part of the manufacturing team but will also be required to work in collaboration with the development transfer team, acting as trainer for the new processes to be implemented. You will be responsible for Reagent Manufacturing Technicians and will report into the Reagent Manufacturing Team Leader.
- 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 for new processes, creating documentation where required and communicating with Supply Chain
- Support the design, execution and analysis of experiments for improving reagent manufacturing operations.
- Work in collaboration with transfer team to introduce new processes to manufacturing and role out effective training
- Prepare process buffers and stock solutions to allow reagent manufacturing and validation 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.
- Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Responsible for upload of real time material and labour data into ERP system
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and a can do attitude, along with the following experience:
- Degree level qualified, or equivalent, in a science subject. Significant relevant experience may also be considered without a degree.
- 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).
- Can work well within a group environment
- Knowledge of GMP standards, including Validation protocols and Non-Conformances
- Good communication, personal task management skills and high self-motivation
- Good at problem solving and troubleshooting
- Computer literacy, data analysis interpretation skills and good attention to detail
- Experience of working within a biohazard environment
- Commercial diagnostic assay experience
- Experience in statistical analysis techniques
- Line management experience
- Six Sigma Green Belt or Black Belt Qualification
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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