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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 team, you'll play a crucial 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.
- 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.
