Mitsubishi Tanabe Pharma

  • Director, Supply Chain

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1244
    # of Openings
    1
    Category
    Supply Chain
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation, is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    With the recent FDA approval and availability in the U.S. of RADICAVA® (edaravone) MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients. 

     

    The Director, Supply Chain will oversee the supply network and associated inventories to support all product requirements. This individual will help develop supply plans for all phases of clinical and commercial planning and processes.  This includes importation of product for the U.S. and Canada as well as oversight of the Neuroderm project which will include work with ex-U.S. manufacturer of supplies and U.S. contract manufacturer of drug product, device and ancillary infusion materials such as IV tubing and sets. The Director, Supply Chain will work closely with other departments to ensure sufficient RADICAVA® (edaravone) supply, other product supply, and planning for new product introductions.

    Responsibilities

    • Supervises, coaches and develops a high-performing team
    • Maintains budget for supply chain operations
    • Establishes and executes Supply Chain Master Plan over multiple locations and markets in coordination with Mitsubishi Tanabe Pharma Corporation (MTPC) and Neuroderm
    • Collaborates and oversees the development of demand and aggregate forecasts, as appropriate, for input into planning models
    • Works with MTPC to ensure batch release dates are properly prioritized for manufacturing, packaging and labeling timelines based on input from colleagues on the manufacturing, regulatory and quality assurance teams
    • Develops, formally documents, implements and manages supply chain strategies and processes including purchasing and GMP warehouse operations
    • Ensures all supply chain strategies and processes are in compliance with company policies, procedures and applicable regulatory authority directives and regulations
    • Ensures supply chain compliance to GMP documentation requirements and training
    • Leads and/or participates in the selection process of vendors. Leads co-negotiation of agreements with key partners
    • On-boards and manages relationships with vendors, including the establishment of
      agreements, quotes, purchase orders and invoicing
    • Manages inventory reconciliation and partners with Finance for financial closes (i.e. month end)
    • Establishes clear communication and tracking of strategies and scenarios for project teams and senior management
    • Creates, maintains and ensure compliance of Supply Chain related Standard Operating Procedures (SOPs) (i.e. Cold Chain for Neuroderm)
    • Facilitates group training involving initiatives by FDA and other applicable regulatory authorities related to supply chain and documentation
    • Provides oversight for importation/exportation compliance of labeled supplies to the appropriate drug depot and subsequent shipment to the clinical sites (as required)
    • Participates in inspection readiness efforts, ensuring supply chain is fully prepared for both internal and external audits
    • Helps track supply chain deviations and CAPA's, and works to resolve recurring problems with permanent solutions
    • Leads product serialization/track and trace efforts in compliance with new requirements for both the U.S. and Canada and Neuroderm product
    • Leverages controlled room temperature and cold chain expertise to guide selection of shippers and couriers
    • Develops and finalizes packaging and design for PI's and PPI for all labelling
    • Manages credits processing, returns approvals and management of chargebacks reporting and approvals
    • Works on government reporting of chargebacks and trade units sold per month

    Qualifications

    • Bachelor’s degree in pharmaceutical/biotech supply chain or similar major
    • MBA preferred
    • Requires a minimum of 10 to 15 years of experience in Supply Chain Operations in pharmaceuticals or bio-pharmaceuticals.
    • At least 5 years of experience in management with at least 3 years of experience managing operations in an outsourced manufacturing environment.
    • Experience with “cold chain”, 3 PL partners and Specialty Pharmacies is preferred.
    • In-depth knowledge of planning/scheduling, purchasing, inventory management, logistics, GMPs, cGCPs, GDPs, and other relevant regulations in U.S..
    • Bias for action and sense of urgency.
    • Strong skills in leadership, communication, project management, and budget management.
    • Willingness to travel up to 25 percent domestically and internationally.

    Physical Demands

    • Ability to sit or stand for long periods of time
    • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
    • Carry, handle and reach for objects
    • Lift and pull up to 15 pounds

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