Regulatory Scientist in Cell and Gene Therapy

3 weeks ago


London, Greater London, United Kingdom Orchard Therapeutics Full time

As a Regulatory Scientist in Cell and Gene Therapy, you will play a critical role in ensuring that our products meet the highest standards of quality and regulatory compliance.

You will be responsible for providing expert review and approval of executed batch records, test records, and associated documentation for release of LVVs and plasmids used in their production. The successful candidate will have a PhD or equivalent in biotechnology, process development, cell and gene therapy, or a related scientific discipline, with a minimum of 5 years of experience in the development, manufacture, and delivery of viral vectors, preferably retro and lentiviral vectors.

Key Elements and Responsibilities:

  • Expert review and approval of executed batch records, test records, and associated documentation for release of LVVs and plasmids used in their production
  • Assist in the reporting, investigation, and resolution of deviations encountered during GMP production activities
  • Contribute to the transfer of improved processes to GMP and assist with oversight of manufacturing activities as required

Salary Estimate: £70,000 - £100,000 per annum, depending on experience.



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