Director, Bioanalytical Diagnostic Development Lead
2 months ago
Orchard Therapeutics, a global biotechnology gene therapy company, is seeking a highly skilled 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 development strategy and leading all activities related to clinical bioassays/diagnostics.
Key Responsibilities- Develop and implement a global bioanalytical development strategy for Orchard's gene therapies.
- Lead the development, validation, and transfer of bioanalytical assays.
- Manage 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.
- Review and approve method development and/or validation reports prepared by lab vendors.
- Perform data reviews to ensure assays are fit for purpose.
- Conduct gap analysis and identify logistical constraints to sample collection, shipping, stability, processing.
- Ensure concordance for bioassays performed in more than one laboratory.
- Author clinical study protocol sections related to bioassays, reports, and regulatory documents.
- Solid experience in pharmaceutical industry and/or CRO with exposure to the overall lifecycle of therapeutic asset development.
- Experience 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.
- Proven experience working with complex matrices and cell isolation, ideally also exposure to technologies required for cell and gene therapy products.
- Proven track record in managing Central laboratory services and multiple laboratory providers.
- Experience of bioassay/diagnostic gap analysis, corrective actions, and process improvements.
- Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package.
- Proven ability to develop strategic relationships with academic, biotech, and clinical partners.
- Strong leadership, communication, mentorship, and project management skills.
- Effective in engaging collaboratively and cross-functionally adopting a problem-solving and non-linear thinking approach.
- Able to work independently and take initiative.
- Successful working in a matrix role, engaging closely with external partners and internal SMEs.
Masters degree in life science, cell and molecular biology, biochemistry, or related field. PhD in the above fields would be ideal.
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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 timeAbout This RoleOrchard 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...
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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 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 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...
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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 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 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 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 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 gene therapy company, is seeking a highly experienced professional to lead the development of bioanalytical strategies and diagnostics for our innovative gene therapies. As a key member of our Clinical Development Team, you will be responsible for defining and executing global bioanalytical development...
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Clinical Bioassay and Diagnostic Expert
2 months ago
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 our innovative gene therapies. As a key member of our Clinical Development Team, you will be responsible for defining and executing global bioanalytical development...
