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Research Scientist

2 months ago

Cambridge, Cambridgeshire, United Kingdom SRG Full time

Job Opportunity

Production Scientist - IVD

About the Role

This is a newly created position at SRG, working in a flourishing biotech environment. You will report to the Senior Production Scientist and support key duties in the manufacture and quality control of specialist reagents.

  • Preparation of reagents, lyophilisation, and quality control of small-medium scale batches.
  • Handling receipt of reagents and chemicals, including aliquoting, storage, and uploading onto the Quality Management System as necessary.
  • Collaboration with Contract Manufacturing Organizations (CMOs) and in-house specialists to support production scaling activities.
  • Development and implementation of quality control and validation protocols, ensuring adherence to regulatory processes.
  • Reporting of quality control pass and fails, monitoring non-conformance, and taking corrective action.
  • Adherence to Standard Operating Procedures (SOPs), maintaining accurate records, and documenting production activities in accordance with company policy.
  • Background in an In Vitro Diagnostics (IVD) development setting, working to ISO 13485 standards in a production or quality control team.
  • Proven industry/commercial laboratory experience, ideally in a setting with devices in development.
  • Good proficiency with Real-Time Polymerase Chain Reaction (RT-PCR) and other classic molecular skills, such as reagent and/or chemical handling.