Dedicated to transforming the lives of patients with inherited diseases through innovative gene therapy.
What you'll be doing
- Working in the laboratory to develop and/or re-optimize new and existing analytical methods for the lot release and characterization of HSC-derived gene therapy products with specific cell-based potency assay development expertise.
- Routine operation of potency assays and other analytical methods to support characterisation of HSC-derived gene therapy products as required.
- Overseeing analytical method development and optimization with external partners as required.
- Execution, review and approval of method development reports, protocols and process documents as required.
- Assisting in the preparation of CMC regulatory submissions.
- Assisting with comparability protocol design and execution as required
- Minimum of three years of experience in the biotechnology or pharma industry with a primary focus on the development of analytical methods for product development, characterization and lot release testing.
- Demonstratable experience of development and optimization of cell-based assays (e.g. FACS, HTRF, ELISA, Luminescence, etc) for lot release and characterization.
- Demonstratable experience of engineering cell lines to include (e.g.) vector construction, exogeneous expression of cell surface receptor(s), single cell cloning, etc,
- Demonstratable experience of characterization and maintenance of transfected, clonal and primary cell lines.
- Knowledge of analytical method qualification and validation.
- Experience with the development and application of analytical techniques, including Capillary Electrophoresis, DNA sequencing, qPCR/PCR, ddPCR.
- Experience of the characterization and lot release testing of viral vector-based and/or cell-based products desirable.
- Sound understanding and demonstrated application of statistical methods/tools.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- PhD in Biological Sciences, Bioengineering, Chemistry or an associated discipline or Masters of Science
- Work from home opportunities
- Health insurance
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