Scientific Production Specialist

4 weeks ago


Cambridge, Cambridgeshire, United Kingdom SRG Full time

Job Title: Scientific Production Specialist

Job Summary:

We are seeking a highly skilled Scientific Production Specialist to join our team at SRG. As a key member of our production team, you will be responsible for the manufacture and quality control of specialist reagents.

Key Responsibilities:

  • 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 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.

Requirements:

  • 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.


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