Analytical Scientist

7 days ago

London, Greater London, United Kingdom X4 Life Sciences Full time

X4 Life Sciences is seeking a highly skilled QC Analytical Scientist to join our team in the UK. As a key member of our Quality Control team, you will be responsible for ensuring the testing of gene therapy products and associated materials meets EU and FDA GMP requirements.

The ideal candidate will have a strong background in Human Health or Sciences and experience working in a regulated industry, such as pharmaceuticals or biologics. You will be proficient in EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and Six-Sigma.

Key responsibilities will include:

  • Testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines.
  • Operation and maintenance of laboratory equipment to ensure all equipment is calibrated and suitable for use.
  • Record of out of specifications, non-conformances, investigations, analysis, and implementation of corrective action(s) as applicable.
  • Maintenance of QC facilities to meet GMP requirements and support health authority, customer, and stakeholder site visits.
  • Support and external or internal audits as required.

Your background:

  • Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry.
  • Demonstrated knowledge/experience of a GMP environment and quality control within a pharmaceutical or other regulated industry.
  • Proficiency in a body of information required for the job, such as knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

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