Celldex Therapeutics

  • Quality Control Analyst II

    Job Locations US-MA-Fall River
  • Overview

    As a Quality Control (QC) Analyst II at Celldex Therapeutics, you will be responsible for 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 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

    • Perform in-process, release, stability, and raw material testing on product and materials according to Product Specifications, SOPs, stability protocols and USP/EP.
    • Performs routine projects with minimal supervision; compiles accompanying reports and/or data summaries.
    • Support environmental monitoring and USP Purified Water and Pure Steam systems monitoring and testing.
    • 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.
    • Assist in training of new employees.
    • Perform inventory of laboratory chemicals and supplies and order supplies.
    • Maintain equipment
    • Independently identifies problems with proposed solutions, actions and/or experimental designs.

    Qualifications

    Required Skills:        

    • Working knowledge of analytical test methods (e.g. raw material testing, microbiological assays, ELISA, HPLC, CE, Gel, and cell-based assay)
    • 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 2 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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