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Analytical Scientist

2 months ago

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

X4 Life Sciences is seeking a highly skilled QC Analytical Scientist to join their team in the UK. The successful candidate will be responsible for ensuring the quality of gene therapy products and associated materials used for manufacturing, in accordance with EU and FDA Good Manufacturing Practice (GMP) requirements.

The role is site-based and involves working closely with the Quality Control team to maintain the flow of information, ensure appropriate communications are passed, and maintain information folders with the most recent version/communication.

The key responsibilities of this role include:

  • Testing and Quality Control: Conduct testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule.
  • Equipment Maintenance: Operate and maintain laboratory equipment, ensuring all equipment is calibrated and suitable for use in alignment with the test schedule.
  • Record Keeping: Record out-of-specifications, non-conformances, investigations, analysis, and implementation of corrective action(s) as applicable.
  • Quality Control Team Collaboration: Maintain the flow of information, ensuring appropriate communications are passed, and information folders are maintained with the most recent version/communication.
  • Facility Maintenance: Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer, or stakeholder site visits.
  • Audit Support: Support and participate in external or internal audits as required.

The ideal candidate will have a degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry. They will also have demonstrated knowledge and experience of a GMP environment and quality control within a pharmaceutical or other regulated industry.

The successful candidate will be proficient in a body of information required for the job, including knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.