Senior Analytical Method Development Scientist

3 days ago


Stevenage, Hertfordshire, United Kingdom Freeline Therapeutics Full time
Unlock the Potential of Gene Therapy

At Freeline Therapeutics, we're revolutionizing the treatment of serious and debilitating chronic diseases with our cutting-edge gene therapy platform. As a key member of our dedicated team, you'll play a pivotal role in advancing our science and developing innovative, one-time treatments that set new standards of care.

Key Responsibilities:
  • Manage analytical method transfer and assay validation at Contract Research Organizations (CROs) to ensure regulatory compliance and technical excellence.
  • Partner with research teams to develop strategies for robust method development on analytical methodologies, with the goal of translating them to CROs for validation.
  • Lead analytical sub-teams for project teams, providing leadership for significant tasks such as specification setting, stability, comparability, and more.
  • Support the development of systems and processes for managing Quality Control (QC) release/stability and clinical data generated by third parties for our products, in support of product release and regulatory approval throughout their lifecycle.
Requirements:
  • Bachelor's of Science or equivalent degree.
  • Experience in a Good Manufacturing Practice (GMP) or Good Laboratory Practice (GLP) laboratory in the Pharmaceutical/Biotechnology industry.
  • Thorough understanding of method development and validation requirements, principles, and regulations.
  • Good understanding of drug development and current trends in Analytical Sciences.
  • Knowledge of documentation requirements in a GMP laboratory, including maintenance of data integrity.
  • Experience writing methods, protocols, Standard Operating Procedures (SOPs), and reports.
  • Experience writing IND/BLA sections related to analytical test methods and specifications.
  • Early and late-stage clinical development experience.
  • Significant experience and understanding of the requirements for Quality Control of Investigational Medicinal Products (IMPs), INDs, and more.


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