Immunomedics, Inc.

  • Senior Manufacturing Specialist

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(11/11/2019 7:03 PM)
    Job ID
    2019-1572
    # of Openings
    2
    Category
    Scientific Manufacturing/Production
  • Overview

    Responsible for the operation of mammalian cell culture production processes in compliance with current Good Manufacturing Practice (cGMP) regulations.

    Responsibilities

      • Ensures consistent completion of all the planned manufacturing activities assigned to him/herself.
      • Prepares, assembles, pressure holds, SIP and sterility test 50 L to 2500 L bioreactors.
      • Organize workplace to maximize the throughput and minimize risks of errors.
      • Follow well defined procedures closely, with attention to detail.
      • Document activities accurately and clearly as per GDP.
      • Operate manufacturing equipment according to well defined procedures.
      • Performs daily monitoring of process including post production cleaning of equipment and large-scale cell culture harvest.
      • Minor maintenance of manufacturing equipment.
      • Preparation of supplements, and/or buffers for production.
      • Revise/draft standard operating procedures (SOPs) as necessary.
      • Train new employees on the use of the bioreactors and related process equipment in accordance with the cell culture personnel training procedure and related SOP’s.
      • Organize/trend data, where applicable.
      • Troubleshoot and recommend corrective/preventive actions (CAPAs), where applicable.
      • Draft deviations, CAPAs, and/or change controls, where requested.
      • Revise manufacturing batch records, where applicable.
      • Ensure shift activities are performed in accordance with the schedule in order to support organizational Key Performance Indicators (KPIs).
      • Proactively communicate and escalate to management any outstanding issues, or concerns of a compliance, quality, safety, or any other critical matter.
      • It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.

    Qualifications

    • Must possess strong communication (oral and written), organizational, and interpersonal skills.
    • Ability to work well within a team environment.
    • Ability to document clearly and accurately as per GDP.
    • Ability to follow SOPs as written.
    • Possess strong aseptic technique.
    • Be proficient with MS Office.
    • Train new manufacturing specialists as per established SOPs.
    • Mentor and lead by example.
    • Have an aptitude for troubleshooting.
    • Be proactive in identifying, communicating and escalating issues.
    • Ability to closely review documentation as per GDP.
    • Ability to forecast and plan for daily manufacturing activities.

    Education

    • Associates/Bachelor’s degree in the sciences or engineering discipline with 4+ years’ experience in a cGMP manufacturing industry setting or equivalent work experience.

    Physical Requirements and Working Conditions 

    • Environment: Work is in a cleanroom environment with exposure to some caustic chemicals. Also exposed to moving mechanical parts.  Other duties are performed in a standard office setting with exposure to computer screens.  Ability to work varying shifts and potentially be on-call as needed.
    • Physical: Must undergo a company-paid post offer/pre-employment physical examination (health surveillance clearance with general eye exam) and receive clearance to work from the attending physician prior to starting employment. Must pass gowning qualifications
    • Equipment Used:
    • Office Equipment
    • Laboratory Equipment and/or Related Manufacturing Equipment (e.g., pH/Conductivity meters, scales, spectrophotometers, biosafety cabinets, XDUO Mixers)
    • Hand Tools (e.g., torque wrench)
    • Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
    • Hearing: Hear in the normal audio range with or without correction.



    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed