Technology Quality

2 weeks ago

Glasgow, United Kingdom LumiraDx Full time

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.
Responsible for ensuring delivery of validated assays into the manufacturing department that achieve the consistently high quality required for progression to Production and that meet the Design for Manufacture requirements. Responsible for the routine manufacture of validated assays to meet production timelines through the management of day-to-day activities and performance of the multiple department Teams. You will be responsible for ensuring a validated manufacturing environment is maintained and oversee investigations and process improvement opportunities. You will have people management and development responsibilities for a Team of technicians and scientists.
You will manage a team of technicians and scientists in a GMP environment responsible for manufacture of reagents for commercial sale and related validation activities. Also responsible for transfer of new processes and test methods from development into the manufacturing department. 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 Scientists and Technicians as direct reports within a designated team and will report into the Manager, Reagent Manufacturing.
Experience of validation activities and operating within a GLP manufacturing laboratory environment.
Line management experience
Detailed knowledge and experience of high volume, commercial immunoassay (or similar) manufacture and testing.
Computer literacy, data analysis interpretation skills and good attention to detail
Plan and schedule all resources for validation activities and reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements.
Provide ‘voice of customer’ input and work in conjunction with R&D to drive transfer of scalable, robust processes and test methods into manufacture which will meet all reagent and strip production needs.
Facilitate purchase of suitable equipment for the manufacture and testing of reagents including the creation of related documentation, service contracts and validation activities required for use.
Ensure new raw material and consumable availability for newly introduced processes and timely upload of real time material and labour data into ERP system
Support FMEA and H&S risk assessment activity, to ensure all risks to product and people associated with reagent manufacture are sufficiently mitigated/controlled.
Ensure the reagent manufacturing processes and associated testing on shift are carried out safely and efficiently.
Design, execute and analyse appropriate experiments for assessing and improving batch to batch performance and reagent manufacturing operations in general.
Quality/Regulatory Compliance
Ensure full GMP, GDP and GLP compliance within the reagent manufacturing department.
Coordinate creation, update and appropriate review of manufacturing SOPs, WIs, BRs and protocols and provide technical review.
Follow and comply with all relevant internal quality and H&S processes and procedures and ensure compliance within the reagent manufacturing department.
Degree level qualified, or equivalent, in a science subject is desirable however equivalent relevant work experience will also be considered.
This role is shift based, please find the pattern below

All shifts are 12 hours, 7am to 7pm or 7pm to 7am
Salary:£50,226Shift 24/5 Shift allowance 20%
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

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.
Please clickhereto seehow we process your data.

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