Advaxis

  • Associate, Manufacturing

    Job Locations US-Princeton
    Posted Date 2 weeks ago(7/5/2018 11:12 AM)
    ID
    2018-1123
    # of Openings
    1
    Category
    Biotech/Pharmaceuticals
  • Overview

    The Manufacturing Associate will perform various biological manufacturing unit operations which includes aseptic cleaning, media/buffer preparation, fermentation, clarification and purification in a cGMP clinical manufacturing facility. Initial job responsibilities will include working with a group of manufacturing personnel responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation.

     

    Responsibilities

    Biologics Manufacturing

    • Effectively demonstrates/develops understanding of GMPs and how they apply to specific responsibilities.
    • Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
    • Identifies, escalates and documents events and subtle variances that deviate from normal operation; Cooperates in investigations as needed.
    • Maintains cleanliness and orderliness of process area.
    • Maintains production area with supplies.
    • Performs aseptic processes including cell banks and transformation of cells.
    • Performs Prepares and operates bioreactor systems and TFF operations, and/or media/buffer preparation operations.
    • Performs logbook and batch record review, procedure revisions, and work order generation.
    • May be responsible for training less experienced or new operators.
    • Plays an active role in process improvements

    Qualifications

    EXPERIENCE:  

    • Minimum of 1-5 years’ experience in a cGMP manufacturing environment.

     

    EDUCATION:

    • High school diploma/GED with 3-5 years of relevant experience
    • BS with 1-3 years of relevant experience

     

    SPECIALIZED KNOWLEDGE, LICENSES, CERTIFICATIONS:

    • Effectively uses process automation systems to operate production processes
    • Experience in reviewing and creating controlled documents.
    • Familiarity with Deviation Management Systems
    • Thorough knowledge of the cGMP regulations.
    • Demonstrated abilities for problem solving, working as a key member of a team, and motivation to complete company objectives.

     

    WORKING CONDITIONS:

    • Ability to lift over 40 pounds.
    • Ability to stand for 6 hours in a production suite.
    • Ability to gown and gain entry to manufacturing areas.
    • Ability to work flexible work

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