• Associate Director, Platform and Early Stage Downstream Process Development

    Job Locations US-MA-Bedford
    ID
    2019-1072
    Category
    Downstream PD
    Type
    Full Time Salary
  • Overview

    The successful candidate will be an integral part of a fast paced and rapidly growing group of scientists and engineers developing purification processes for the manufacture of our proprietary adeno-associated virus (AAV) based gene therapy and gene editing products. Responsibilities will include helping to develop and oversee the development of multiple unit operations with an emphasis on chromatographic separations. Critical to this role is the ability to lead the end to end development of a purification process and to be able to effectively communicate results through high quality technical reports and oral presentations.

    Responsibilities

    • Lead and manage groups in the development of Phase I/II and Phase III/BLA ready purification processes
    • Plan and execute studies related to the recovery and purification of AAV from cell harvest through final formulation.
    • Plan and execute pilot scale production to support process development and research activities
    • Lead the tech transfer of GMP processes to internal and external manufacturing organizations
    • Be a separation science leader within the organization
    • Present development studies results and process development progress.
    • Lead the authoring of technical reports and CMC sections for regulatory filings.

    Qualifications

    • A strong background in the fundamentals and scale-up of chromatographic based separations with biologic molecules
    • Experience with development of purification processes for AAV and/or other viral vectors or vaccines is highly preferred
    • Late stage process development and process characterization experience is desired
    • Direct management experience of purification teams is required
    • Demonstrated ability to work effectively in a cross-functional team
    • Strong verbal and written communication skills

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