Immunomedics, Inc.

  • Director Clinical Drug Supply

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(9/13/2018 1:35 PM)
    Job ID
    2018-1104
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    This position will be responsible for providing clinical supply plans, packaging configurations and distribution strategies.

    Responsibilities

    • Converts protocol into packaging and distribution plan.
    • Manages and selects suppliers for clinical packaging and labeling.
    • Manages internal review and approval of clinical labels and packaging records.
    • Completes technical review of completed clinical packaging batch records.
    • Works with QA supplier to release clinical trial material in a timely manner.
    • Manages the review of deviation investigations and resolving temperature excursions.
    • Develops short and long range demand and packaging plan to insure 100% drug availability for every patient visit.
    • Manages international distribution and logistics for multiple clinical programs.
    • Maintains complete drug accountability files to support post-study product reconciliation, returns and destruction
    • Strong understanding of GMP/GCP; industry procedures and regulations.
    • Strong understanding of clinical study design, execution and drug product supply logistics.
    • Knowledge in cold chain logistics management.
    • Excellent verbal and written communication skills.

     

    It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.

    Qualifications

    • Bachelor’s degree in life sciences or equivalent. Advanced degree or MBA preferred.
    • Minimum 8 years’ experience within pharmaceutical/biotechnology industry.
    • Minimum 5 years of global clinical supply management experience.
    • Experience managing international clinical trials with multiple depots.
    • Travel: 20%

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