Careers

Commercial Labeling Development Specialist

Location: Bedford, MA

Position Summary:

The Commercial Labeling Development Specialist will be responsible for leading and project managing the global packaging and labeling service for Pre-Commercial and Commercial Supply. This role will project manage the cross functional work of Regulatory Affairs, Quality Assurance, Packaging and Commercial to define product labeling and packaging requirements for new commercial products and potential changes or process improvements in our commercial product. The position will be required to work closely with several functional departments including Operations, US Commercial, International Sales & Marketing, Quality Assurance, Regulatory Affairs and Third-Party Vendors. This position will report to into the head of supply chain with location preferably in Bedford, MA, but Franklin, MA or Sarasota, FL also an option.

Key Responsibilities:

  • Work with our commercial label vendors to manage the creation and revision of labeling for product labels, packaging materials, and instructions for use that meet medical, legal, and regulatory requirements
  • Work with Regulatory Affairs and Quality Assurance on label copy changes
  • Manage our vendors in coordinating the language translation activities, as required, and facilitate the review, approval, and release of all labeling components from development to commercialization
  • Work with engineering to ensure proper Unique Device Identification coding (UDI), barcoding and GTIN numbers globally, per regulations and standards
  • Develop, establish, and maintain global packaging standards (standards, templates, dyelines, process, compliance) to leverage internal and external capabilities
  • Work with a cross functional team to manage the specifications, packaging specs, change controls, version controls and SOPs related to commercial packaging and labeling
  • Work with R&D and engineering on development of new packaging components for late-stage programs
  • Assist regulatory team as required with NDC coding, UDI coding, NDA/PMA module writing, draft labeling process and monitoring FDA and global guidelines and requirements for label control.
  • Manage labeling vendor relationships executing QBRs
  • Participate in new packaging vendor selection process

Job Complexity:

The job requires the ability to act on problems of diverse and technical scope, requiring critical thinking and interaction with internal and external technical professionals.  The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.

Supervisory Responsibilities:

No direct reports

Required Qualifications:

  • AD/BA in Science, Engineering, Supply Chain or equivalent with 5+ years with direct GMP experience
  • Direct experience in pharmaceutical or device packaging preferred
  • Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Packaging and Labeling
  • Proficient knowledge of packaging and labeling applications (Adobe Illustrator, Adobe Design, Bartender preferred), SAP ERP as well as Microsoft Excel, PowerPoint and Project software required

Desired Experience, Knowledge, and Skills:

  • AD/BA in Science, Engineering, Supply Chain or equivalent with 5+ years with direct GMP experience
  • Understanding of commercial pack out designs, UDI and serialization
  • High attention to detail and demonstrated ability to manage multiple critical path projects concurrently
  • Ability to develop, implement and monitor a metrics performance package for labeling and packaging activities
  • Demonstrated understanding of quality management and documentation systems – especially as related to change control process and product specifications
  • Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics
  • Excellent communication and influencing skills, strong collaboration skills

 

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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.