CMC Bioprocess & Manufacturing for Gene Therapy

Biogen ,
Maidenhead, Berkshire
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Job Description

As member of the CMC Bioprocess & Manufacturing for Gene Therapy organization, you will be an integral part of management and implementation of process development and support for outsourced contract manufacture of Biogen's gene therapy products to support territorial market expansion.He or she will be independently manage complex multi-disciplinary projects. Furthermore provide expert CMC technical support to Regulatory functions to support clinical development in new territories, in particular Japan and Asia Pacific regions. To be successful, the candidate has to demonstrate they can confidently and clearly present data, progress, issues and risks, both verbally and through written reports. Be a self-starter and have the ability to deliver to tight timelines and budgets. Primary Responsibilities Provide expert technical input into selecting, recommending and championing the most appropriate manufacturing method, process development and experimental design Support CMC and reg-CMC activities for territorial expansion outside of US and EU, with expert bioprocessing advice, strategy and opinion Support vendor selection and provide expert technical input into process development, transfer, manufacturing and validation (in particular USP and DSP activities). Technical review and approval of protocols and study reports Reporting of results to asset teams, project teams and senior management as required Attendance at on-site vendor meetings and performance of Person In Plant (PIP) dutiesParticipate in defining business processes and data models Typically requires 5-8 years of relevant industrial experience working with biopharmaceuticals Experience working with Advanced Therapy Medicinal Products (ATMPs), especially viral gene therapy, highly desirable Good understanding of cell expansion, fermentation and transfection Good understanding of cell lysis and viral harvesting Extensive understanding of large/macromolecule chromatography and UF/DF Extensive understanding of formulation of viral vectors A detailed understanding of Sterile filtration and Fill / Finish University degree or the equivalent combination of education and experience required Advanced/graduate degree preferred Employment Type: Full-Time_Regular

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