Agenus

  • QC Scientist

    Job Locations US-MA-Lexington
    Job ID
    2018-1380
    Category
    Quality
  • Overview

    Agenus is seeking a dynamic multifunctional Quality Control Scientist with a focus in biological and chemical assays and has experience in instrument qualification.  Based in Lexington, the QC Scientist will be responsible for supporting evaluation of new technologies for testing, method qualification, validation, technology transfer, and assay trending program.   The QC Scientist will work collaboratively with Analytical Development and Quality Assurance to generate necessary protocols, reports, and change controls.  The QC Scientist will be a Subject Matter Expert for QC Assays.

    Responsibilities

    • Lead method qualifications, transfer, and validation by writing protocols and reports in compliance with ICH guidance’s and industry standards. Ensure all aspect of method performance are compliant with procedural requirements such as reference materials, critical reagents, and equipment.
    • Work directly with the Process Analytical Development group to optimized test methods and provide data and the statistical rationale for any proposed changes.
    • Assist in the evaluation and implementation of new QC instrumentation. Interact with Metrology, Validation and Computer Validation to ensure qualification is executed.  May author equipment qualifications and SOPs. 
    • Manage contract testing laboratories testing. Assist in troubleshooting and evaluation of test methods performed and data generated by contract laboratories.
    • Participate in Investigations and Change Control for revisions to Item Specifications, Test methods, QC Systems. Revise test method and procedures.
    • Assist with QC data review

    Qualifications

    • BS/MS in relevant scientific discipline and 10+ years’ experience (including 2+ years in a QC laboratory setting) in GMP operations. Masters Degree preferred.
      Strong knowledge of GMP compliance and Quality Control.
    • Expert knowledge with the following methodologies: HPLC, UPLC, SDS-PAGE, Western Blot, MS, cGE, Bioassay, ELISA as well as common QC techniques.  Understanding of FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of therapeutic biologics.  Knowledge of statistics, required.
    • Experience in writing protocols, SOPs, reports, and other controlled documents
    • Strong understanding of analytical method lifecycle, including assay qualification, validation, transfer, and maintenance
    • Ability to work independently and cooperatively with team members
    • Strong written and verbal skills, required

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