Reagent Manufacturing Shift Analytical 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 based at our Stirling site and will involve 24/7 shift work.
We are currently recruiting for a Reagent Manufacturing Shift Analytical Scientist to work within our reagent manufacturing department and be responsible for performing analytical test methods as required for all reagent manufacturing materials to assess their quality, performance and impact on final product performance and ensure delivery of consistently high quality assay reagents to production. You will also be responsible for investigation and improvements on existing test processes and supporting routine manufacture of reagents where required.
- Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing to support manufacturing activities, work to established test specifications.
- Prepare process buffers and stock solutions to allow reagent manufacturing, testing and validation schedule to be met.
- Support preparation and manufacture of assay reagents safely, efficiently and in line with schedule and SOPs/WIs to meet strip production requirements.
- Carry out routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
- Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of all reagents.
- Ensure raw material and consumable availability for new test methods, creating documentation where required and communicating with Supply Chain
- Execute validation and ongoing monitoring of analytical test methods and equipment.
- Support development and transfer of new analytical test methods for raw materials, intermediates and final manufactured assay reagents.
- Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
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 qualified in a relevant scientific discipline including Analytical Chemistry.
- Experience and strong knowledge of HPLC/UPLC, FCM, DLS, Rheology, MS, UV/Visible spectrophotometry, and related wet chemistry techniques.
- 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 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.
- Knowledge of Nanoparticles and Antibody Conjugates.
- 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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