Radius Health, Inc.

  • Director, External Supply Chain Operations

    Job Locations US-PA-Wayne
    Posted Date 4 weeks ago(9/28/2018 3:33 PM)
    Job ID
    2018-1838
    # of Openings
    1
    Category
    Pharmaceutical Sci - Dept
  • Overview

    The Director, External Supply Operations manages the relationship and activities of key contract manufacturing organizations (CMOs) within the Radius commercial supply chain network.  The role serves as strategic lead and primary point of contact for all cross-functional activities at the manufacturing sites and ensures contractual commitments are honored by both parties.  The Director, External Supply Operations is accountable for the overall performance of assigned CMOs.

     

    Additionally, the role will oversee personnel and performance for product labeling activities, including both clinical and commercial needs.

    Responsibilities

    • Collaborates with internal cross-functional teams and CMO to determine manufacturing requirements, execute the plan, and identify and mitigate key risks
    • Drives contract manufacturer capability and capacity to enable on-time and predictable delivery of product
    • Identifies and champions process improvement solutions to complex issues impacting CMOs
    • Leads team of cross-functional stakeholders on all CMO matters (Tactical & Strategic)
    • Manages the operational activities (schedule, timelines, etc.) of the CMO ensuring program cost, quality, metrics, delivery and technology objectives are met as well as manage the partner performance to achieve them. Intercedes if goals and timelines are jeopardized, communicating to appropriate stakeholders as needed.
    • Develops and executes Supplier Governance Model to ensure appropriate controls and oversight are in place
    • Partners with key stakeholders in the preparation for Requests for Quotes (RFQs), Statements of Work (SOW) and Supply Agreements
    • Serves as the manufacturing outsourcing leader on cross-functional teams as requested in support of all supply chain related activities.
    • Partners with Quality Assurance to ensure CMO is in compliance with all cGMP guidelines and SOP requirements
    • People management and accountability of GMP Labeling function
    • Leads strategic sourcing activities for external manufacturing category

    Qualifications

    • Bachelor of Science degree in Engineering, Supply Chain, or Business is required; Advanced degree preferred
    • Minimum 8 years Manufacturing, Supply Chain, Engineering, or Supplier Management
    • 5+ Years Pharmaceutical industry experience is required
    • Direct and proven experience working with CMOs and with GMP Labeling processes is required
    • Direct project experience with New Product Launches
    • Experience in developing and documenting supply chain processes
    • Knowledge of logistics operations including; production, transportation, warehousing and materials management
    • Demonstrated success in project planning, resource management, liaison with engineering and manufacturing resources.
    • Familiarity with risk management tools (FMEA, etc)
    • 3-5 years of team and/or people leadership is required
    • Strong analytical and creative problem-solving skills.
    • Strong compliance orientation within a Pharmaceutical environment and attention to detail.
    • Effective communicator at all levels; excellent written, oral and interpersonal communications and presentation skills.
    • Up to 25% travel (domestic and global)

     

    Work Environment:

    The work is performed in a typical office environment with heavy computer duties.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet.   Frequent travel required.  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

     

     

     

     

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