Director, Bioanalytical Diagnostic Development
4 weeks ago
Orchard Therapeutics, a global biotechnology gene therapy company, seeks a strategic leader to define the global bioanalytical development strategy and lead all activities related to clinical bioassays/diagnostics.
This role requires a subject matter expert with a strong track record in bioanalytical development, regulatory compliance, and laboratory operations. The successful candidate will ensure bioassay readiness requirements are achieved during study protocol design through to execution.
Key Responsibilities- Develop and execute the global bioanalytical development strategy
- Lead the development, validation, and transfer of bioanalytical assays
- Ensure regulatory compliance of diagnostic development and associated bioanalytical laboratory operations
- Partner with Clinical Science and Regulatory Science teams to provide subject matter expertise for diagnostic development
- Manage laboratory vendors and contract development
- Master's degree in life science, cell and molecular biology, biochemistry, or related field
- PhD in the above fields preferred
- Experience in pharmaceutical industry and/or CRO with exposure to the overall lifecycle of therapeutic asset development
- Proven experience in bioanalytical development, regulatory compliance, and laboratory operations
Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies.
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