Immunomedics, Inc.

  • Director, Drug Product and Formulations Development

    Job Locations US-NJ-Morris Plains
    Posted Date 2 days ago(12/11/2019 11:22 AM)
    Job ID
    2019-1540
    # of Openings
    1
    Category
    Process Sciences
  • Overview

    Responsible for leading the Drug Product development and validation of all commercial and clinical products under cGLP and cGMP guidelines.

    Responsibilities

    • Lead the development of stable formulations (liquid and/or lyophilized) for antibodies and antibody drug conjugates.
    • Lead the development/optimization of scalable, efficient and cost-effective conjugation and purification of ADCs.
    • Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
    • Participation in laboratory bench work as needed (small department).
    • Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into a cGMP drug product manufacturing facility.
    • Be responsible for the technical management of third party drug product manufacturers.
    • Provide technical support for commercial manufacturing activities.
    • Work closely with other scientists and associates in the Process and Manufacturing Sciences Department to assess product quality and product stability.
    • Represent the Drug Product group on Program Teams and/or subteams.
    • Provide mentoring for associate scientists.
    • Provide organizational leadership in all areas related to formulation, fill & finish work.
    • Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals.
    • Assign resources according to priority and project needs.
    • Provide data and metrics across the department and to senior management on a regular basis.

    Qualifications

          • PhD in the biology or chemistry-related disciplines and 10+ years industry experience or a BS/MS and 15+ years industry experience.
          • Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products.

    • Lead a team of 2 – 3 scientists in the Drug Product group of Process and Manufacturing Sciences.
    • Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation.
    • Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work.
    • Written and oral communication. Authoring of protocols, reports and parts of regulatory filings. Internal and external presentations.
    • Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements.
    • Solid understanding of cGMPs and compliance requirements.

    Prior experience interacting with the FDA during inspections.

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