Immunomedics, Inc.

  • Manufacturing Specialist I-Upstream

    Job Locations US-NJ-Morris Plains
    Posted Date 3 days ago(12/6/2018 2:44 PM)
    Job ID
    2018-1362
    # of Openings
    2
    Category
    Scientific Manufacturing/Production
  • Overview

    We are seeking a Manufacturing Technologist I- Upsteam to be responsible for the manufacturing of clinical products in compliance with current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOPs).

     

    Primary schedule will run Monday through Friday alternating between 6:00am-2:30pm and 10:00am-6:30pm, though occasional variation to those hours may be required.  

    Responsibilities

    • Operate automated protein purification system for large scale purification of monoclonal antibodies using ion-exchange and affinity column chromatography.
    • Perform virus removal filtration.
    • Prepare buffers (up to 200 L each).
    • Perform integrity tests (filter/membrane).
    • Maintain inventory of raw materials and supplies needed in manufacturing.
    • Daily maintenance and calibration of all equipment needed during production.
    • Monitor and assure adequate supply of glassware/components for manufacturing.
    • Maintain accurate batch records, log books, and log sheets.
    • Write/revise batch records, buffer sheets, SOPs, and Material Safety Sheets (MSSs).

    Qualifications

    • Bachelor’s degree in biology, chemistry, or related discipline, plus 0-1 years of industry experience in large scale protein purification, or equivalent combination of education and experience.
    • Proficiency with automated purification software (e.g. UNICORN) is desired.
    • Ability to follow SOPs and cGMP guidelines and regulations.
    • Must possess excellent communication (oral and written) and interpersonal skills. 
    • Detail oriented with strong organizational, follow-through, and problem-solving skills.
    • Must be able to work collaboratively in a team environment. 
    • Must be proficient with MS Office applications. 

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