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London, Greater London, United Kingdom Orchard Therapeutics Full timeOrchard Therapeutics, a global biotechnology company focused on gene therapy innovation, seeks a driven and experienced Director, Bioanalytical Diagnostic Development to join our growing team. As a key member of the Clinical Development Team, you will play a pivotal role in shaping the bioanalytical strategy for our groundbreaking gene therapies. You will...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a Director, Clinical Bioanalytical Diagnostic Development to lead the development of innovative, potentially curative gene therapies for rare diseases. The successful candidate will be responsible for defining the global bioanalytical development strategy and leading all...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly skilled Director, Clinical Bioanalytical Diagnostic Development to join its team. As a key member of the Clinical Development Team, this individual will be responsible for defining the global bioanalytical development strategy and leading all activities related...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly skilled Director, Clinical Bioanalytical Diagnostic Development to join its team. As a key member of the Clinical Development Team, this individual will be responsible for defining the global bioanalytical development strategy and leading all activities related...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly experienced professional to lead the development of bioanalytical strategies and diagnostics for its innovative gene therapies. As a key member of the Clinical Development Team, the successful candidate will be responsible for defining the global bioanalytical...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly experienced professional to lead the development of bioanalytical strategies and diagnostics for its innovative gene therapies. As a key member of the Clinical Development Team, the successful candidate will be responsible for defining the global bioanalytical...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology company, is seeking a highly skilled professional to lead the development of bioanalytical diagnostic strategies and assays for its gene therapy products. The successful candidate will be responsible for defining the global bioanalytical development strategy, managing development, validation, and...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology company, is seeking a highly skilled professional to lead the development of bioanalytical diagnostic strategies and assays for its gene therapy products. The successful candidate will be responsible for defining the global bioanalytical development strategy, managing development, validation, and...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a Director, Clinical Bioanalytical Diagnostic Development to join its team. As a key member of the Clinical Development Team, this individual will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a Director, Clinical Bioanalytical Diagnostic Development to join its team. As a key member of the Clinical Development Team, this individual will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly skilled Director to lead the development of innovative, potentially curative gene therapies for rare diseases. The successful candidate will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly skilled Director, Clinical Bioanalytical Diagnostic Development to join its team. As a key member of the Clinical Development Team, this individual will be responsible for defining the global bioanalytical development strategy and leading all activities related...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly skilled Director, Clinical Bioanalytical Diagnostic Development to join its team. As a key member of the Clinical Development Team, this individual will be responsible for defining the global bioanalytical development strategy and leading all activities related...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a Director, Clinical Bioanalytical Diagnostic Development to join its Clinical Development Team. The successful candidate will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical...
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London, Greater London, United Kingdom Orchard Therapeutics Full timeJob SummaryOrchard Therapeutics, a global biotechnology gene therapy company, is seeking a Director, Clinical Bioanalytical Diagnostic Development to join its Clinical Development Team. The successful candidate will be responsible for defining the global bioanalytical development strategy and leading all activities related to clinical...
Lead Bioanalytical Diagnostic Development for Gene Therapies
2 months ago
About Orchard Therapeutics
Orchard Therapeutics, a global biotechnology company recently acquired by Kyowa Kirin, is dedicated to transforming the lives of people affected by rare diseases. We achieve this through the development of innovative, potentially curative gene therapies using an ex vivo autologous approach. This method harnesses the power of genetically modified blood stem cells to correct the underlying cause of disease in a single administration. Orchard has its global headquarters in London and U.S. headquarters in Boston.
About the Role
We are seeking a highly motivated and experienced Lead Bioanalytical Diagnostic Development professional to join our growing team. In this role, you will play a critical part in the development and implementation of innovative diagnostic assays for our gene therapy programs. You will lead a team of scientists and collaborate closely with cross-functional teams to ensure the success of our clinical trials and product launches.
Responsibilities
- Lead the development, validation, and implementation of novel bioanalytical assays for gene therapy products, including quantitative PCR (qPCR), next-generation sequencing (NGS), flow cytometry, and other relevant technologies.
- Develop and maintain strong relationships with external CROs and diagnostic laboratories to ensure high-quality assay performance and data integrity.
- Collaborate closely with clinical scientists, regulatory affairs, and manufacturing teams to ensure seamless integration of diagnostic assays into clinical trials and product development processes.
- Contribute to the preparation of regulatory submissions for diagnostic assays, including briefing documents, IND/MAA modules, and other relevant documentation.
- Stay abreast of the latest advancements in bioanalytical technologies and their applications in gene therapy diagnostics.
Qualifications
- Master's degree or PhD in life science, cell and molecular biology, biochemistry, or a related field.
- Extensive experience (5+ years) in the development and validation of bioanalytical assays for therapeutic products, preferably with a focus on gene therapies.
- Strong understanding of regulatory requirements for diagnostic assay development and validation (e.g., FDA, EMA).
- Proven ability to lead and manage teams of scientists and collaborate effectively with cross-functional stakeholders.
- Excellent communication, interpersonal, and problem-solving skills.
