Reagent Manufacturing Shift Analytical Scientist

Location

Glasgow, UK

Job Type

Permanent

Company Overview

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

Opportunity 

This role will be based at our manufacturing site in Glasgow and will involve 24/7 shift work.

You will work within a shift team of technicians and scientists in a GxP environment to test raw materials and manufactured reagents for commercial sale and use in 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 report into the Reagent Manufacturing Shift Team Leader.

You will be responsible for performing analytical test methods as required for all reagent manufacturing materials (raw/in-process and final formulations) to assess their quality, performance and impact on final product performance and ensure delivery of consistently high quality assay reagents to production. Responsible for investigation and improvements on existing test processes and supporting routine manufacture of reagents where required. Will execute validation activities for introduction of new analytical test methods and support ongoing monitoring of data produced.

Key Responsibilities: 

  • 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.
  • Adhere to all relevant regulatory GxP requirements.
  • Lead in the creation and update of SOPs/WIs as required
  • Ensure creation and update of COSHH assessments, acting as technical review, and follow and comply with all relevant internal quality and H&S processes and procedures.
  • Raise Non-conformances, lead investigations and corrective actions and support other team members.
  • Accurately complete batch records and reports, recording and communicating all process observations and deviations.
  • Technically review process documentation and reports, and provide feedback to team members to support a Right First Time culture.

Required Experience

About you:

Essential Skills:

  • Degree level qualified, or equivalent, in a science subject 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.
  • 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.
  • Knowledge of GMP standards, including Validation protocols and Non-Conformances.
  • Ability to work 12 hour shifts to support 24/7 manufacture.

Desirable Skills:

  • Experience of working within a biohazard environment.
  • Commercial diagnostic assay experience.
  • Experience in statistical analysis techniques.
  • Six Sigma Green Belt or Black Belt Qualification.
  • Knowledge of Nanoparticles and Antibody Conjugates.

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.

 

For further information and to apply for this role, please click APPLY

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process 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.