Celldex Therapeutics

  • Quality Control Analyst III

    Job Locations US-MA-Fall River
  • Overview

    As a Quality Control (QC) Analyst III at Celldex Therapeutics, you’ll be responsible for everything associated with routine and non-routine lab work assigned by departmental management at our Fall River MA facility.

    If you have laboratory experience in the biotechnology / pharmaceutical industry and want to work in a collaborative small team environment with a great group, this is an opportunity you’ll want to explore!

    Celldex Therapeutics, Inc. is developing a pipeline of immunotherapy and targeted cancer therapies. We are conducting clinical trials across multiple product candidates.

    Responsibilities

    • In-process and release testing to support manufacturing; release and stability testing on finished product according to product specifications, SOPs, stability protocols, and USP / EP.
    • Operate complex instrumentation, including maintenance and troubleshooting.
    • Checks/reviews data generated by routine and non-routine analysis and finalize data reports using appropriate computer systems.
    • Perform routine and non-routine projects independently and compile accompanying reports and/or data summaries; database entry for trending programs and data filing; and create and edit SOPs.
    • Training new and junior employees.
    • Perform inventory of laboratory chemicals and supplies and order supplies.
    • Independently identifies problems with proposed solutions, actions and/or experimental designs.

    Qualifications

    Required Skills:        

    • Strong working knowledge of analytical methods (analytical test methods (e.g. raw material testing, microbiological assays, ELISA, HPLC, CE, Gel, and cell-based assay) as well as method transfer experience.
    • Strong working knowledge of analytical equipment and the associated software.
    • Self-driven, organized, adaptable to change, and can work independently under minimal supervision

    Education/Experience:

    • Bachelor’s degree in Biology, Chemistry, or related discipline.
    • A minimum of 5 years of working experience in the biotech / pharmaceuticals industry, including hands-on experience in a cGMP laboratory and familiarity with standard concepts, practices, procedures, instrumentation and software in a Quality Control organization.

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