Production Specialist

1 week ago

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

Cambridge

Permanent

£ Competitive depending on skills, background and experience

Role Overview

This is a newly created role working for a flourishing biotech organisation based near to Cambridge, UK. You will report to the Senior Production Scientist and support with 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.
  • Strictly adhere to all ISO 13485/FDA regulations.
  • Follow SOP's, maintaining accurate records and document all production activities in accordance with company policy.
Your Background
  • BSc or equivalent in a Biological discipline (or related).
  • 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.
  • Must have a good command of operating within a QMS.
  • Exemplary attention to detail, methodical approach and accustomed to working in a busy and demanding environment.
  • Strong communication and organisational skills; able to collaborate well within a multidisciplinary environment.

Are you a motivated and detail-oriented individual with a passion for biotechnology? If so, we encourage you to apply for this exciting opportunity.

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