Immunomedics, Inc.

  • Senior Director, Manufacturing Technical Operations

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(7/11/2019 10:26 PM)
    Job ID
    2019-1477
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    Immunomedics is seeking a strong leader with experience in monoclonal antibody and/or antibody drug conjugate manufacturing. The candidate must have knowledge of mammalian cell culture and large scale protein purification. Candidate must have a working knowledge of cGMPs

    Responsibilities

    • Guide a group of process, automation, and validation engineers in the execution and support of late stage clinical and commercial biologics manufacturing operations
    • Participate in process and technology transfers to CMOs
    • Support of GMP manufacturing for monoclonal antibody, Drug Linker, and antibody Drug Linker combination including leading investigations
    • Documentation generation and maintenance of manufacturing quality systems
      • Specification and Qualification of new equipment
      • Deviation investigation, CAPA generation, and closure
      • Trending and Statistical Analysis of Upstream, Downstream, and Release Data
    • Leading Risk Assessment and Process Validation to support process improvements
    • Lead Process Automation activities to ensure consistent and reliable process operation
    • Work with Finance to develop and maintain COGs calculation model
    • Lead troubleshooting and process optimization efforts for equipment and process
    • Assist in generation of relevant regulatory submissions
    • Implementation and maintenance of cGMP compliant systems that support process validation and new equipment introduction
    • Lead introduction of new manufacturing processes into the Morris Plains facility

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