Reagent Manufacturing 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 

We have an exciting opportunity to join our growing and talented Reagents Manufacturing team.

You will predominantly be based at our Glasgow Manufacturing site, however we require a degree of flexibility as this role will work across multiple sites including Glasgow and Stirling, working days (Monday to Friday – 08:30 to 17:30). 

You will work within a team of technicians and scientists in a GxP environment to facilitate the validation and transfer of new process and test methods from development into the manufacturing department. You will also provide support where required to manufacture and test reagents for commercial sale and related validation activities. You will be part of the manufacturing team but will also be required to work in collaboration with the development transfer team, acting as trainer for the new processes to be implemented. You will report into the Reagent Manufacturing Team Leader.

You will be responsible for implementation and validation of new analytical test methods into the manufacturing department for all reagent manufacturing materials (raw/in-process and final formulations) that relate to final product performance and provide understanding of the Critical to Quality elements of reagent manufacture. This is to achieve the consistently high quality required for reagent progression to Production and ensure they meet the Design for Manufacture requirements.  Responsible for performing ongoing process improvement activities for existing assays.

Key Responsibilities: 

  • Work with R&D to identify, develop and transfer relevant and robust analytical test methods for raw materials, intermediates and final manufactured assay reagents.
  • Establish test specifications for critical raw materials and stages of manufacture that are final product performance impacting.
  • Perform full validation on analytical test methods and plan ongoing monitoring
  • Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of reagents.
  • Ensure raw material and consumable availability for new test methods, creating documentation where required and communicating with Supply Chain
  • Support the design, execution and analysis of experiments for improving existing reagent manufacturing test methods.
  • Work in collaboration with transfer team to introduce new tests to manufacturing and roll out effective training.
  • Prepare process buffers and stock solutions to allow reagent manufacturing, testing and validation schedule to be met.
  • Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing to support manufacturing activities.
  • Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.

Required Experience

About you:

Essential Skills:

  • Degree level qualified, or equivalent, in a science subject.
  • 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.
  • 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.

    Desirable Skills:

    • 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.

     

    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.