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.
We have an exciting opportunity to join our growing and talented Reagents Manufacturing team.
This role will be based at Alloa, Stirling site and will involve working a 24/7 shift work.
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 the ongoing manufacture and testing of reagents and related components to ensure the supply of consistently high quality reagents to meet production requirements, while maintaining a compliant GMP laboratory environment.
* Report into Shift Scientist daily for prioritisation of tasks and assist with communication and scheduling to Technicians
* Ensure raw material and consumable availability through routine stock checks and requisitions, communicating with Supply Chain and creating documentation where required.
* Prepare process buffers and stock solutions to allow reagent manufacturing schedule to be met.
* Real time data entry of material usage into electronic trackers to maintain accurate stock levels and departmental costings.
* Manufacture assay reagents safely and efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
* Ensure Technicians on processes are trained to perform activities prior to execution
* Ensure manufacturing area is maintained to the required standard through execution of defined cleaning procedures as scheduled
* Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
* Carry out routine calibration and maintenance of laboratory and analytical equipment and arrange maintenance activities with external suppliers and engineers where required.
* Raise Purchase Orders for new equipment, repairs and services as needed and coordinate suitable delivery the department.
* 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.
* Accurately complete batch records and reports, recording and communicating all process observations and deviations.
* Raise Non-conformances and support investigations and corrective actions.
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and people development, along with the following experience:
* Previous experience working within a scientific manufacturing or laboratory environment
* Knowledge of GLP and GMP standards including Non-Conformances
* Confidence working with minimal supervision in a laboratory environment and adhering to EHS standards
* Ability to follow complex protocols and accurately complete batch records
* Experience of accurate electronic data entry
* Good at problem solving and troubleshooting
* Computer literacy, data analysis interpretation skills and good attention to detail
* Good communication, personal task management skills and high self-motivation
* Can work well within a group environment and act as a trainer to others
* Ability to work 12 hour shifts to support 24/7 manufacture
* Degree level qualified, or equivalent, in a science subject
* Commercial diagnostic assay, or similar industry experience
* Experience of working within a biohazard environment
* Experience using electronic QMS and Purchasing systems
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