Immunomedics, Inc.

Manager, Drug Product Supply Chain

US-NJ-Morris Plains
1 month ago
Job ID
2017-1028
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

We are seeking a Manager, Drug Product Supply Chain to provide operational support for commercial and clinical manufacturing, labeling, and distribution of antibody drug conjugates.  He/she will ensure all Contract Manufacturing Organizations (CMOs), Contract Packaging Organizations (CPOs), Suppliers, Third-Party Logistics (3PL), and Logistics providers meet our demands, and follow current Good Manufacturing Practice (cGMP) and International Conference on Harmonization (ICH) guidelines.  This individual acts as primary contact for all External Manufacturing, Supply, and Distribution interactions, which includes responsibility for maintaining excellent supplier relationships and timely production and delivery schedules. The position works cross-functionally with internal departments and external resources on Supply Chain-related issues. The Manager, Drug Product Supply Chain supports adherence to relevant regulatory requirements and Company Standard Operating Procedures (SOPs) as appropriate.  The position reports to the Executive Director, Manufacturing Supply Chain.

Responsibilities

  • Directs planning, scheduling, and provides oversight for CMO and Clinical Research Organization (CRO) activities with respect to production of clinical and commercial drug product supplies.
  • Supports Sales and Operations Planning (S&OP) process in partnership with commercial team; develops and maintains accurate forecasts for commercial supplies to meet market demand.
  • Ensures proper execution of qualification and validation of process controls for packaging and labeling activities for commercial and clinical product supply.
  • Oversees process performance qualification and process validation execution.
  • Fulfills the needs of the clinical supply chain function by ensuring that clinical demands for drug supplies are fully met and all study patients are served without interruption globally.
  • In partnership with clinical development, develops and maintains accurate forecasts for clinical supplies for on-going and new clinical trials.
  • Manages packaging, labeling, and shipping of clinical supplies to investigator sites.
  • Manages packaging, labeling, and shipping of commercial supplies with 3PL activities to meet commercial distribution.
  • Establishes and manages shipping and distribution activities within Good Distribution Practice (GDP) and International Safe Transit Association (ISTA) guidelines.
  • Ensures that all shipments reach their destination on time, undamaged, and cost effectively.  
  • Supports development and management of Master Services and Master Supply Agreements.
  • Participates and sometimes leads regularly scheduled Business Review meetings with partners.

Qualifications

  • Bachelor’s degree in a scientific or engineering discipline and a minimum of  8 + years of experience or a Master’s degree or Ph.D. with 5+ years of experience in a pharmaceutical, biotechnology, CMO, or related environment; or the equivalent combination of education and experience.
  • Knowledge of biologics drug product manufacturing processes focused on packaging and labeling.
  • Knowledge of serialization and commercial distribution.
  • Experience with clinical trial material distribution.
  • Knowledge of GDP and global distribution regulations.
  • Excellent verbal and written communication skills.
  • Demonstrated strong collaboration and interpersonal skills and a high degree of personal integrity.
  • Experience in matrix management.
  • Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple, concurrent projects. 
  • Cross functional team and project management experience.
  • Experience working with both domestic and international CMOs.
  • Travel requirements - 25-30%; May include international travel.

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