Immunomedics, Inc.

  • Quality Control Scientist- Protein Characterization

    Job Locations US-NJ-Morris Plains
    Posted Date 5 days ago(5/21/2019 4:42 PM)
    Job ID
    2019-1423
    # of Openings
    1
    Category
    Other
  • Overview

    This is a hands-on role acting as a site subject matter expert on characterization and management of reference standards. Through coordination of in-house and contract laboratories, the QC Scientist – Protein Characterization coordinates the sourcing, manufacture, testing and release of product reference standards for antibody drug conjugate products and product intermediates, provides technical input and manages the supply of product reference standards, ensuring continuity of supply across a global network of in-house and contract GMP testing laboratories. Responsibilities include development of testing protocols, review of batch records, release of test results and control of inventory.

    Responsibilities

    This technical subject matter expert in characterization of biomolecules:

    • Develops and maintains the reference standards program in compliance with regulatory guidelines, ensuring that a continuous supply of fully qualified materials are available for GMP release and stability testing.
    • Authors and maintains program level documents, develops specifications and qualification documents required for release.
    • Develops detailed protocols for full characterization, coordinates all testing and compiles comprehensive reports supporting release of reference standards,
    • Identifies source materials (manufactured in-house and externally) for use in filling product reference standards. Provides support for development and release of critical custom laboratory reagents and controls.
    • Tracks inventory and collaborates with Supply Chain, internal and external contract laboratories to ensure continuity of supply. Manages the reference standards inventory throughout the life-cycle with appropriate supporting documentation (e.g. change management).
    • Verifies compliance with applicable policies and guidelines and ensures consistency among site procedures and/or specifications
    • Provides technical support for monitoring and evaluating the performance of analytical methods to demonstrate method suitability.
    • Ensures that all QC personnel have adequate training in the handling and use of reference standards to effectively execute testing.
    • Participates in compliance-focused teams working towards the goal of continuous improvement of the reference standards program.
    • Participates in the site team which authors, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.

    Qualifications

    • PhD. degree in Biochemistry, Molecular Biology or a related field and three (3) years, or M.S. degree and five (5) years of relevant experience in analytical development for biotherapeutics.
      Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
    • Experience with pharmaceutical and biotechnology product development.
    • Must be a technical/scientific expert in analytical methods commonly applied to protein characterization, including stability assessment and determination of degradation pathways.
    • Direct experience with reference standards development, manufacture and control is a plus.
    • Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
    • Able to operate independently where appropriate, yet escalate issues as appropriate, establishes effective cross functional working relationships.
    • Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
    • Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.
    • Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single site, project or collaboration.
    • Must have strong verbal, technical writing and presentation skills.

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