Immunomedics, Inc.

  • Quality Control Associate Scientist

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(7/11/2019 10:19 PM)
    Job ID
    2019-1476
    # of Openings
    1
    Category
    Quality
  • Overview

    The QC Associate Scientist, Raw Materials, is responsible for routine testing of incoming raw materials for release and adventitious virus safety testing of bioreactor harvests, both inhouse and at third party provider. This position includes responsibility for validation and technical transfer of test methods, including the preparation of validation protocols and reports, authoring technical reports, specifications for incoming raw materials and evaluation of change notifications.

    Responsibilities

    • Works in a cGMP QC laboratory setting, responsible for raw material testing in house and providing oversight of testing at a third party provider. Ensures timely delivery of test results to meet deadlines for release of raw materials, and process intermediates.
    • Accountable for maintenance performance of instrumentation and documenting any routine or preventative maintenance in the system.
    • Performs timely and accurate reviews compendial or raw material supplier change notifications, assessment of the impact on raw materials testing and implementation of the changes.
    • Effectively participates validation and technical transfer of analytical methods in compliance with FDA, compendia and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.
    • Implementation of spectroscopy based identity testing for incoming raw materials

    Qualifications

    • Bachelor’s degree in chemistry or related discipline and 1 to 3 years of experience in a Biopharmaceutical and/or Biotechnology environment; or equivalent combination of education and experience.
    • Prior cGMP/GLP training and experience working in a cGMP/GLP environment required.
    • Works in a cGMP QC laboratory setting, responsible for raw material testing in house and providing oversight of testing at a third-party provider. Ensures timely delivery of test results to meet deadlines for release of raw materials, and process intermediates.
    • Accountable for maintenance performance of instrumentation and documenting any routine or preventative maintenance in the system.
    • Performs timely and accurate reviews compendial or raw material supplier change notifications, assessment of the impact on raw materials testing and implementation of the changes.
    • Effectively participates validation and technical transfer of analytical methods in compliance with FDA, compendia and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.
    • Implementation of spectroscopy based identity testing for incoming raw materials
    • Experience with development, transfer and implementation of analytical method validation based on FDA and ICH guidelines.
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
    • Must be able to work in a team environment and perform job responsibilities under minimal supervision. 
    • Must be proficient with QMS deployed to support GMP quality operations

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