Reagent Manufacturing Scientist (Shift)
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
You will be working 24/7 shifts in a 365 day Manufacturing Operation. Please note that shift patterns and shift allowance will be dependent on business needs.
We are currently recruiting for a Reagent Manufacturing Shift Scientist to work within our reagent manufacturing department. You will work within a shift team of technicians and scientists in a GMP environment to manufacture 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 Technicians on a designated shift and will report into the Reagent Manufacturing Shift Team Leader.
- 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 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 day to day activities responsible within the shift, and organisation of workload and team members
- 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.
- Ability to create and follow complex protocols and accurately complete batch records
- Computer literacy, data analysis interpretation skills and good attention to detail
- Can work well within a group environment
- Knowledge of GMP standards, including Validation protocols and Non-Conformances
- Ability to work 12 hour shifts to support 24/7 manufacture
- Knowledge of in-process testing such as electrochemical, fluorescent and particle analysis methods (e.g. Flow Cytometry, Dynamic Light Scattering).
- Good communication, personal task management skills and high self-motivation
- Good at problem solving and troubleshooting
- Experience working within a manufacturing laboratory following good lab practices and confidence to work without supervision
- Experience of working within a biohazard environment
- Experience in statistical analysis techniques
- Line management experience
- Six Sigma Green Belt or Black Belt Qualification
- Commercial diagnostic assay experience
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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