Immunomedics, Inc.

  • Associate Director Contract Manufacturing (CMO)

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    2018-1264
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    Associate Director CMO provides oversight of the CMO manufacturing site(s). Provides project management and operational support for commercial and clinical manufacturing operations for the manufacture of Drug Linker cytotoxic small molecule and Bulk Drug Substance in the Supply of Antibody Drug Conjugates at Contract Manufacturing Organizations (CMOs). The selected candidate acts as primary contact for assigned manufacturer(s) and assists in maintaining excellent supplier relationships and timely production schedules.

    Responsibilities

    • Provides project management oversight of CMO operations and strategies for ensuring supply chain using CMO
    • Provides production process troubleshooting including travel to CMOs to monitor production; interfaces with CMOs and internal departments to facilitate the manufacture, and release of drug product.
    • Coordinates and executes activities related to drug linker and drug substance technology transfer, validation and process improvements at manufacturing partners.
    • Monitors existing vendors' activities.  This includes, but may not be limited to, reviewing vendor batch records, change orders, distribution procedures and invoices.
    • Coordinates the authoring, execution and issuance of drug linker and drug substance process development, registration and validation protocols and reports; supports the authoring and review of the manufacturing-related sections of regulatory submissions (domestic and international).
    • Evaluates external vendors/resources necessary to ensure the successful execution of drug linker and drug substance supply plans, contributes to the development of Requests for Proposals (RFPs), participates in contract negotiations and facilitates the execution of legal documents required to engage the vendor’s services
    • Assists in the development and maintenance of budgets.
    • Assists in the identification, development and implementation of policies, procedures and standards which impact the department, while working to ensure compliance with applicable regulatory requirements.
    • Performs other tasks and assignments as needed and specified by management. 

    Qualifications

    • BS in Life Sciences, Sciences or equivalent with 10+ years related experience within a pharmaceutical or Biotechnology Company.
    • Additional technical experience in an area allied with cGMP Quality, Phased approach to Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines
    • Strong understanding of pharmaceutical manufacturing processes for antibody drug conjugates, or biologics and/or small molecules
    • Experience in manufacturing batch record review leading to lot release
    • Experience with CMO management is necessary
    • Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
    • Strong EQ and project management skills
    • Travel 40% national and international

    Home base flexible – virtual team member skills advantageous

    Options

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