Immunomedics, Inc.

  • GMP - Reference Standard Manager

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(7/22/2019 5:23 PM)
    Job ID
    2019-1423
    # of Openings
    1
    Category
    Quality
  • Overview

    This position requires prior experience in product characterization assays and management of in-house primary and working reference standards procedures. Through coordination of in-house and contract laboratories, the Reference Standard Manager (RSM) will coordinate the sourcing, testing and release of product reference standards for antibody drug conjugate products, product intermediates, provides technical input to management.  He /She will also manage the inventory of reference standards, support the Stability Program, ensuring continuity of supply across a global network of in-house and contract testing laboratories. Responsibilities include authoring of testing protocols, test plan, review of batch records, release of test results and maintenance inventory control are described below.

    Responsibilities

    • Prior experience and technical knowledge in Drug characterization of biomolecules:
    • Develops and maintains the reference standards program in compliance with regulatory guidelines, ensuring that a continuous supply of fully qualified materials is available for GMP lot release and stability testing.
    • Works with management to develop detailed protocols for full characterization of Reference Standards. Coordinates all testing and compiles comprehensive reports supporting release of reference standards.
    • Identifies source materials (manufactured in-house and / or 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 of Reference Standards is available for use. Manages the reference standards inventory throughout the life-cycle of the product with appropriate supporting documentation (e.g. change management).
    • Verifies compliance with applicable policies and guidelines and ensures consistency among site procedures and/or specifications
    • Participates in compliance-focused teams working towards the goal of continuous quality improvement of the reference standards program.

    Qualifications

    • Masters or PhD degree in Chemistry, Biochemistry, Molecular Biology or a related field and three (3) years relevant experience in analytical development for biotherapeutics.   
    • Experience in a GMP regulated pharmaceutical and biotechnology product development is preferred.
    • 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, USP, 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, or single project. Works well in collaboration with other teams.
    • Must have strong verbal, technical writing and presentation skills.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed