Mitsubishi Tanabe Pharma

  • Sr Associate, Supply Chain

    Job Locations US-NJ-Jersey City
    Job ID
    2018-1205
    # 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 Associate Manager, Strategy & Supply Chain Operations manages drug supply activities related to planning, labelling development, manufacturing, packaging, and distribution for commercialized products and development. Incumbent actively responsible for and oversees supply plans to ensure accurate and continuous supply to patients while reducing risks. Associate Manager, Strategy & Supply Chain Operations represents his/her assigned supply chain functions to internal stakeholders and manages relationships with external business partners.  Drawing on a working knowledge of pharmaceutical supply chain systems and best practices, as well as experience within international trade, works closely with management to implement process improvements and helps to evolve the organization and systems for current and new products.

    Responsibilities

    • Works collaboratively with corporate partners, Mitsubishi Tanabe Pharma Supply Chain, QA, CMC and functional stakeholders as required to promote continuous supply to patients, reduce risks and ensure stable supply of products for patients.
    • Requests and/or provides documents as needed to support regulatory filing requirements.
    • Assists in creating training materials for SOPs, cGMP, cGDP (Compliance with Good Manufacturing/Distribution Practices); demonstrates adherence and compliance as a model for other colleagues to follow.
    • Evaluates and enhances departmental and company and/or vendor site quality procedures to ensure compliance with company policies; communicates any compliance issues to Director, Supply Chain & Strategy as they arise.
    • Prepares, maintains and distributes, as appropriate, weekly and monthly reports, chain of custody verification, quality trend analysis/quality scorecards, metrics, PowerPoint presentations and projects management.
    • Maintains and keeps track of audit files, meeting minutes, product disposition documents, and non-conformance investigations, departmental SOP’s and work instructions.
    • Prepares product forecasts as required for planning of product supply.
    • Contractual agreements compliance
    • Works on production planning for new products in the MTPA pipeline.
    • Participates on project teams or on-site meetings as directed.
    • Assists in vendor qualification process. Interacts with suppliers and or contracted services, obtains qualification related documents, facilitates the completion of vendor surveys, performs vendor risk analysis and audits, and writes audit reports.
    • Acts as the department Coordinator for the Operations & Strategy Team which includes processing invoices and payment vouchers.
    • Performs other duties as required.

    Qualifications

    • Bachelor’s or master’s degree in Business Administration, Operations Management or Supply Chain Management

    • At least 2 years in the pharmaceutical or biotech industry within Regulatory and or Cost Accounting and Supply Chain roles
    • Experience in a cGMP pharmaceutical environment encompassing change controls, product complaints, returns, audits, nonconformance investigations, data management, weekly reporting, and supply planning
    • Additional required experience: working with service providers, working in a matrix organization, and working with both paper and electronic-based documentation
    • Preferred: Strong Pharmaceuticals US Customs & Canada experience
    • Broad understanding of pharmaceutical product development, manufacturing, contract packaging and DSCSA
    • Broad understanding of US FDA CGMPs, Japanese and Canadian regulatory guidance’s
    • Knowledge of commercial manufacturing requirements in Japan as well as in US regulatory environment
    • Ability to work independently with limited supervision
    • Negotiation and interpersonal skills with a good awareness of global cultural differences; ability to effectively promote coordination between Supply Chain functions within US entities and MTPC Japan
    • Excellent oral/written communication skills including technical writing
    • Proficiency with computer programs such as MS Office (Advanced Excel, Access, PowerPoint, Word), SAP, ISO-Train, Track-Wise or similar databases
    • Willingness to travel 20% domestically and internationally  
    • Ability to sit or stand for long periods of time
    • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
    • Ability to carry, handle and reach for objects
    • Ability to lift and pull up to 15 pounds

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