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Research Scientist

2 months ago

Cambridge, Cambridgeshire, United Kingdom ZipRecruiter Full time
Production Scientist - IVD

Permanent Opportunity

This is a newly created role working for a flourishing biotech organisation based in the UK. You will report to the Senior Production Scientist and support key duties in the manufacture and QC of specialist reagents.

Key Responsibilities:

  • Preparation of reagents, lyophilisation and quality control and production of small-medium scale batches.
  • Handling receipt of reagents and chemicals - including aliquoting, storage and uploading onto the QMS as necessary.
  • Working alongside CMO's and in-house specialists to support the production scaling activities.
  • Create and implement QC and validation protocols, ensuring that regulatory processes are followed meticulously.
  • Report any QC pass and fails, monitoring any non-conformance closely and taking corrective action.
  • Follow SOP's, maintaining accurate records and document all production activities in accordance with company policy.

Requirements:

  • Background in an IVD development setting, working to ISO 13485 standards in a production or QC team.
  • Proven industry/commercial lab experience, ideally where there are devices in development.
  • Good proficiency with RT-PCR along with other classic molecular skills such as reagent and/or chemical handling.