Reagent Manufacturing 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 GMP 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 be responsible for Reagent Manufacturing Technicians and will report into the Reagent Manufacturing Team Leader.

You will be responsible for validation of new 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 performing ongoing process improvement activities for existing assays. You will have people management and development responsibilities.

Key Responsibilities: 

  • Provide feedback and evaluation support to R&D to aid delivery of suitably robust processes and test methods.
  • 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 processes, creating documentation where required and communicating with Supply Chain
  • Support the design, execution and analysis of experiments for improving reagent manufacturing operations.
  • Work in collaboration with transfer team to introduce new processes to manufacturing and role out effective training
  • Prepare process buffers and stock solutions to allow reagent manufacturing and validation schedule to be met.
  • Manufacture assay reagents safely, efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
  • Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
  • Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
  • Responsible for upload of real time material and labour data into ERP system.
  • Adhere to all relevant regulatory GLP, GMP and GDP requirements.
  • Lead in the creation and update of SOPs, WIs and validation protocols as required and coordinate appropriate technical review
  • 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, lab books 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.
  • 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 in-process testing such as electrochemical, fluorescent and particle analysis methods (e.g. Flow Cytometry, Dynamic Light Scattering).
  • Knowledge of GMP standards, including Validation protocols and Non-Conformances.

    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.
    • Line management 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

    APPLY

    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.