Immunomedics, Inc.

  • Director, Downstream GMP Manufacturing

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(11/7/2018 12:29 PM)
    Job ID
    2018-1363
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    The Director Downstream GMP is responsible for leading the downstream GMP manufacturing operations. The Director will serve as a subject matter expert and provide strong technical and organization leadership for the GMP manufacturing organization effectively supporting monoclonal antibody purification operations. The individual must manage manufacturing operations including but not limited to planning, GMP preparation, act as receiving and sending unit for technology transfer, and day-to-day operational decision making. The incumbent will work closely with a cross functional team of Process Development, Tech Transfer, Quality Assurance, Facilities, Engineering, and Project Management to ensure production operations are safe and right-first-time. The Director will adhere to all Safety and Quality standards of the organization and contribute to continuous improvement in the areas of Safety, Quality, Delivery, Cost, and People.

    Responsibilities

    • Manage a production team performing cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule
    • Provide on the floor oversight as needed leading right-first-time production operations
    • Act as a subject-matter-expert on cGMP and antibody purification techniques (e.g. chromatography, tangential flow filtration, viral filtration.)
    • Ensure meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards
    • Through strict adherence to manufacturing controls, ensure finished drug substance and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards
    • Adheres to the production schedule ensuring on-time delivery and efficient production logistics
    • Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)
    • Other duties as assigned
    • Supervises 2 Managers, and approx.14 Technologists (operators)

    Qualifications

    • Master’s degree preferably in business, engineering, science, or a related field with a minimum of 6 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 4 years’ experience in a managerial position; OR
    • Bachelor’s degree preferably in business, engineering, science or a related field with a minimum of 8 years’ experience preferably in Biotechnology or Pharmaceutical Operations with at least 4 years’ experience in a managerial position.
    • cGMP experience.
    • Must have a minimum of 5 years supervisory experience in downstream production Biologics

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