• Senior Associate - Manufacturing

    Job Locations US-Princeton
    Posted Date 2 months ago(10/5/2018 3:41 PM)
    # of Openings
  • Overview

    The Senior Associate, Manufacturing 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.



    Biologics Manufacturing:

    • Effectively demonstrates 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; Actively participates as needed in investigations.
    • Owns and executes CAPAs and CCRs
    • Maintains cleanliness and orderliness of process area.
    • Maintains production area with supplies.
    • Independently performs aseptic processes including cell banks and transformation of cells.
    • Independently 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.
    • Utilizes manufacturing knowledge to improve process operations and affect positive change.
    • Demonstrates ability to troubleshoot basic mechanical operations.



    • Excellent communication and coordination skills.
    • Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
    • Ability to influence in a cross-functional environment.
    • Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.


    • High school diploma/GED with 5-7 years of relevant experience or BS with 3+ years of relevant experience


    • Effectively uses process automation systems to operate production processes
    • Experience in reviewing and creating controlled documents.
    • Familiarity with Quality 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.


    • 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 hours.



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