Celldex Therapeutics

  • Manufacturing Associate I

    Job Locations US-MA-Fall River
  • Overview

            The Associate is responsible for performing all activities within the production facility to produce biopharmaceutical products. 

    Responsibilities

    • Cleaning, weighing, mixing and process monitoring, performance testing of materials/supplies (i.e. integrity testing of filters).
    • Assisting in Purification of Monoclonal antibodies used in Phase I and II clinical trials.
    • Write and revise standard operating procedures (SOPs), material specifications and master batch records in compliance with Good Manufacturing Practices (GMP) guidelines.
    • Assembly, disassembly and operation of bioprocess and laboratory equipment such as Chromatography Columns, filter assemblies, and TFF setups.
    • Prepare buffers, media, and other solutions needed for manufacturing practices.
    • Cross train in Cell Culture using up to 1000L Bioreactor.

    Qualifications

    Required Skills:

    • Demonstrate mechanical aptitude and good manual dexterity.
    • Ability to occasionally lift up to 55 pounds.
    • Availability for extended day and/or night shifts as needed.
    • The ability to work in a clean room environment with good aseptic technique.
    • Ability to read, write, understand and work from SOP.
    • Word processing ability including Microsoft Word, Excel, PowerPoint, and Outlook.
    • The ability to work independently and as part of a team.

    Education/Experience:

    • AS/BA/BS in Biology, Chemistry or Life Sciences or Biotechnology Certificate.
    • 0-2 years of experience in Biotech/Pharma industry.
    • 0-2 years of experience in GMP.

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