Bioanalytical Development Leader
1 day ago
The Bioanalytical Development Leader at Orchard Therapeutics will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical bioassays/diagnostics. This role requires a strategic thinker with a strong track record serving as a subject matter expert within a matrix organisation.
The successful candidate will have solid experience in the pharmaceutical industry and/or CRO, with exposure to the overall lifecycle of therapeutic asset development. They will have expertise in the development, validation, and sample testing of assays required for cell and gene therapy products.
Key Responsibilities:
- Develop and implement a global bioanalytical development strategy
- Lead all activities related to clinical bioassays/diagnostics
- Ensure bioassay readiness requirements are achieved during study protocol design through to execution
- Manage regulatory compliance of diagnostic development and associated bioanalytical laboratory operations
Requirements:
- Solid experience in the pharmaceutical industry and/or CRO
- Expertise in the development, validation, and sample testing of assays required for cell and gene therapy products
- Awareness of bioanalytical guidelines particularly in the context of cell and gene therapy products (FDA, EMA, MHRA)
Salary: $120,000 - $180,000 per annum
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