Radius Health, Inc.

  • Director, Packaging Engineering

    Job Locations US-PA-King of Prussia
    Posted Date 3 weeks ago(6/5/2018 8:59 AM)
    Job ID
    2018-1780
    # of Openings
    1
    Category
    Pharmaceutical Sci - Dept
  • Overview

    The Director, Packaging Engineering will focus on package development, packaging operations, labeling, security and project management for Supply Chain. Responsibilities include facilitating the implementation and approval process for GMP commercial packaging components, artwork, and documentation for precommercial to commercial products. This includes integration of complex programs that may require multinational interactions and cross functional partnerships. The Director of Packaging Engineering will collaborate with Regulatory Affairs and Quality to participate in development, review, implementation and systems support of GMP labeling.

    Responsibilities

    • Manages technical requirements of labeling to ensure it meets the technical standards/specifications for GS1, the contract manufacturer organizations (CMO)’s, printer, etc.
    • Manages technical requirements and specifications for all packaging components for clinical and commercial product supply to meet manufacturing and compliance requirements.
    • Manages projects associated with packaging line operation improvements and/or implementations.
    • Coordinates and manages the change control process for all GMP labeling modifications.
    • Employs measures for counterfeit protection to implement overt and covert anticounterfeiting technologies.
    • Manages internal documentation requirements including change controls specifications, item code creations, pertinent SOPs and artwork libraries.
    • Coordinates review, obtains internal approvals and ensures labeling is in compliance with Quality system requirements, GMP and applicable domestic, international regulatory requirements and anti-counterfeiting provisions.
    • Collaborates with Regulatory Affairs, coordinating artwork translations.
    • Oversees generation of final proof copy/transparency proof and creation of print-ready artwork files. Serves as the primary information base for all issues related to product labeling/printed components and clinical packaging and labeling.
    • Ensures labeling artwork generated is in conformance with source text.
    • Supports Regulatory Affairs in packaging responses to Health Authorities.
    • Tracking of all versions, specifications and coding for each labeling component for all GMP and updates.
    • Follows GS1 standards and UPC/GTIN number assignment.
    • Ensures US DSCSA and EU FMD implementation and compliance.
    • Acts as a Project Manager for discreet projects with the Supply Chain department.
    • Supports day to day departmental logistics and inventory management.
    • Supports AX ERP and Serialization management.

    Qualifications

    • BS/BA required, Masters preferred (packaging engineering, supply chain or similar; science degrees will be considered); with 10+ years of related Industry experience. 
    • Understanding of US and EU regulations on packaging implementation is preferred.
    • Demonstrated experience in commercial pharmaceutical and/or medical device packaging development and applications is required.

    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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