Immunomedics, Inc.

  • Associate Director, MSAT

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(11/11/2019 6:36 PM)
    Job ID
    2019-1568
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    The Associate Director, MSAT will be the technical and leadership resource for the MSAT department, purposed to provide engineering and scientific expertise to tech transfer, process scale-up, equipment and process optimization, technical document authoring, continuous improvement, equipment and process quality system ownership, and on-the-floor mentorship for all large-scale processing. 

    Responsibilities

    • Lead a multi-functional team of engineers and scientists to ensure robust tech transfer and process scale-up
    • Serves as the large-scale process and equipment expert, utilizing technical and engineering tools to troubleshoot and/or optimize the process.
    • Manages the team in analyzing data and creating trending grafts and reports. Conducts routine data trending meetings and discussions with cross functional teams. Trouble shoots and resolves equipment and process issues.
    • Manages the team to serve as a technical resource and SME for large-scale process and equipment projects and activities.
    • Takes ownership of all technical based quality systems, including change controls, deviations, and CAPAs. Work with Manufacturing and QA to properly manage quality system investigation and closure.
    • Authors technical documents, including but not limited to Tech Transfer protocols, DOE protocols, Campaign summary reports, Process data reports, and CMC sections as appropriate.
    • Manages the team to improve process throughput, utilizes modeling tools to identify bottlenecks and improve throughput.
    • Manages the team to serve as on-the floor experts for all process runs as directed by the Manufacturing Head.
    • Manages the team to assist with SOP and MBR improvements.
    • Manages the team to perform risk assessments/recommendations. Assists with equipment failure risk mitigation, FMEA analysis, process safety assessments, and critical spare part assessments.
    • Manages the team to implement process improvements. Specifies and purchases new equipment for process improvements. Supports Validation and Manufacturing departments for validation of new equipment or processes.

    Qualifications

    • BS in appropriate engineering or science discipline with at least 8 years of industry experience and a minimum of 4 years in a leadership role at a regulated facility. Additional and equal relevant experience in lieu of formal education will be considered.
    • Experience leading teams in planning and execution of technical related activities.
    • Experience with staff performance evaluation and management, succession/progression planning, and improvement planning.
    • Strong technical writing experience.
    • Excellent technical and analytical skills.
    • Thorough knowledge of Upstream, Downstream, and Single Use technologies
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills.
    • Strong understanding of cross-functional leadership, decision-making, and influence.
    • Comfortable with respectfully challenging convention.
    • Ability to manage up, down, and across levels and departments.
    • Must have ability to work in fast paced environment with an in-process infrastructure

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