Immunomedics, Inc.

  • Vice President, Manufacturing

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(9/17/2018 11:26 AM)
    Job ID
    2018-1283
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    The new Vice President of Manufacturing, Antibody will join a team that is building outstanding clinical, manufacturing and commercial infrastructure and taking meaningful steps toward effectively treating patients with significant unmet medical needs. This position reports to the EVP, Global Manufacturing Operations and has full responsibility to manage all cGMP manufacturing activities based at the Immunomedics campus in Morris Plains, New Jersey. This includes the commercial manufacture of the IMMU-132 antibody intermediate as well as future clinical manufacturing  of the IMMU-132 antibody intermediate that will provide products for the growing pipeline and expansion into different therapeutic indications.

    Responsibilities

    • Direct oversight of all antibody manufacturing activities in the commercial manufacturing facility.
    • Provide technical services leadership and oversight of the manufacturing technical services group in support of commercial manufacturing goals and objectives.
    • Provide organizational leadership in all manufacturing/production processes and projects including antibody production plan development and execution against the antibody production plan.
    • Work collaboratively and cross-functionally with other key leaders to ensure the proper execution of organizational goals.
    • Manage the department budget consistent with organization and corporate goals
    • Assign resources according to priority and project needs.
    • Provide data and metrics across the department and to senior management on a regular basis.
    • Represent the Manufacturing function during Regulatory Authority inspections.
    • Cultivate and maintain external relationships with third party suppliers and CMO partners to support the manufacture of IMMU-132 and other clinical candidates. 

    Qualifications

    • PhD in the biology or chemistry-related disciplines (Microbiology, Biochemistry, Chemical Engineering) and 10+ years experience or a BS/MS and 15+ years experience in a manufacturing leadership position.
    • Demonstrated experience manufacturing commercial-scale biological products with post-marketing support specifically in the cGMP production of antibody or antibody-related products.
    • Demonstrated experience developing manufacturing strategies for clinical and commercial biological products that mitigate risk, manage cost and ensure product availability over the life cycle of the product.
    • Broad knowledge of the biopharmaceutical industry, including in-depth knowledge of the processes and functions involved in biologics drug development and life cycle management.
    • Fluent in the process development of antibody manufacturing processes and the standard unit operations used in the production of antibodies.
    • Solid understanding of cGMPs, and compliance and quality requirements.
    • Prior experience interacting with the FDA during pre-approval inspections or semi-annual commercial manufacturing inspections.
    • Results Oriented:Establishes clear goals and expectations and effectively allocates resources. Consistently delivers. Has flexible and creative problem-solving skills.
    • Strategic Thinker:Is able to see the big picture and understand the challenging and sometimes conflicting needs within an organization. Thinks logically, develops and evaluates options, and identifies pros and cons. Constantly strives for ways to add value and improve how work is done.
    • Team Leader:Able to manage and lead a group of diverse individuals and assess and nurture talent. Encourages team to present and debate their best ideas and holds the team accountable for results Strong, clear communicator who recognizes that new ideas and approaches require a great deal of communication. Able to communicate across functions and bring people together around a common goal. Able to work effectively with limited direction in a complex, fast-paced environment.

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