Production Specialist

2 days ago


Cambridge, Cambridgeshire, United Kingdom SRG Full time
Job Description

Job Title: Production Scientist

Job Summary:

We are seeking a highly skilled Production Scientist 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
  • 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 production scaling activities
  • Create and implement QC and validation protocols, ensuring 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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