Senior Specialist, Artwork & Label Development

Company: bluebird bio
Location: Somerville
Posted on: January 27, 2023

Job Description:

ABOUT THE FLOCK
Amazing opportunity to join the team that drives Artwork Development, Traceability and Supply Chain Systems within the Patient Supply organization. Fly at the cutting edge of science and be a part of an enthusiastic team of bluebirds and external partners in bringing our approved Gene Therapy products to market, supporting ongoing clinical trial activity and getting ready for launch of the next Gene Therapy. In this role you will work closely with leaders and stakeholders within Apheresis Operations, Therapy Operations and Customer Service, Manufacturing, Quality, Business systems, Regulatory and External Partners and Suppliers.Through strong collaboration with this cross functional flock of stakeholders, this role will support the design and management for commercial and clinical artwork.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:

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• Driving clinical and commercial label design activities. Including, but not limited to, creating labeling/packaging artwork, preparing associated specifications, managing related electronic labeling systems, managing quality systems activities (e.g. change control) and coordinating printing of artwork components for raw and starting materials, clinical product and commercial product.
  
• Reviewing and approving artwork for accuracy, regulatory requirements and production requirements.
  
• Developing solid relationships with external artwork and print suppliers.
  
• Work closely with external artwork and print suppliers to ensure timely readiness of artwork development as well as timely availability of printed components.
  
• Participating in initiatives to enhance labeling design, and associated processes and systems.
  
• Working with cross functional stakeholders including Regulatory Affairs, Quality Assurance, Commercial, Legal, Packaging Engineering, Manufacturing and external partners to collect content, develop artwork, coordinate supply of artwork components and to further refine the process for design & development of clinical and commercial labeling.
  
• Leading creation, review, update (as needed) and approval of functional SOPs and Work Instructions.
  
• Ensuring budget, Purchase Order creation and invoice payments occur on time.
  
  WHAT YOU'LL BRING
  You're the bird we're looking for if you have:
  
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  • 3+ years of experience in the biotech/pharmaceutical device or diagnostic industry including at least 2 years of label design, regulatory affairs or equivalent experience
    
  • Experience with NiceLabel software.
    
  • Strong understanding of FDA regulations and guidelines with the ability to interpret them and a good understanding of GxP label processes.
    
  • Knowledge of FACT/JACIE and ICCBBA Standards
    
  • Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
    
  • Experience with clinical and marketed product labeling, patient information leaflet design
    
  • Knowledge on how to author Standard Operating Procedure documents is a plus.
    

Keywords: bluebird bio, Somerville , Senior Specialist, Artwork & Label Development, Other , Somerville, Massachusetts