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Manager, Translational Sciences

Roles and Responsibilities The Manager in Translational Sciences will be responsible for interfacing with internal scientific experts and with external CROs to manage bioanalytical assay development and validation under applicable regulations and guidances to support specialty lab measurements in early and late stage of gene therapy studies. Responsibilities will include setting up vendor contracts, participating in vendor audits, and managing all aspects of the method development, validation, study sample analysis, and reporting of data. Qualifications and Background Requirements PhD degree or equivalent education and/or experience in a bioanalytical, biological, or biochemical field A minimum of 5 years of experience in a biotech, pharma, or CRO. Professional Experience Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation. Scientific expertise in assessing immune responses to gene therapy products is required. Technical expertise with a wide variety of technical platforms to assess immunogenicity of gene therapy products (e.g., binding and neutralizing antibodies, T cell response, etc...) is required. Demonstrated expertise in GLP compliance of sample handling, bioanalytical assay validation and performance, sample analysis, and laboratory operation procedures and processes is required. Ability to clearly and proactively communicate assay development and validation work in real-time to internal scientific experts and to appropriately incorporate feedback in a timely fashion is required. Ability to conduct on-site visits to CROs to review core capabilities and lab processes, raw data, etc... to ensure GLP compliance and assay data quality, and/or to evaluate and assess the capabilities of new CROs, is required. Ability to manage project resources and timelines for deliverables is required. A demonstrated sense of urgency and ability to work independently and under tight deadlines is required.   Travel 0-25%. 1433
Salary Range: NA
Minimum Qualification
5 - 7 years

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