Production Specialist

7 days ago

Cambridge, Cambridgeshire, United Kingdom SRG Full time

Job Summary:

This is a newly created role working for a flourishing biotech organisation. You will report to the Senior Production Scientist and support with key duties in the manufacture and quality control 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 Quality Management System as necessary.
  • Working alongside Contract Manufacturing Organisations and in-house specialists to support the production scaling activities.
  • Create and implement quality control and validation protocols, ensuring that regulatory processes are followed meticulously.
  • Report any quality control pass and fails, monitoring any non-conformance closely and taking corrective action.
  • Strictly adhere to all ISO 13485/FDA regulations.
  • Follow Standard Operating Procedures, maintaining accurate records and document all production activities in accordance with company policy.

Requirements:

  • Bachelor's degree or equivalent in a Biological discipline (or related).
  • Background in an In Vitro Diagnostics development setting, working to ISO 13485 standards in a production or quality control team.
  • Proven industry/commercial laboratory experience, ideally where there are devices in development.
  • Good proficiency with Real-Time Polymerase Chain Reaction along with other classic molecular skills such as reagent and/or chemical handling.
  • Must have a good command of operating within a Quality Management System.
  • 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.

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