ElevateBio is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies.

Position Summary

Join ElevateBio’s enthusiastic and collaborative team by contributing to the overall success of our revolutionary business model. This is an excellent opportunity to be a part of a growing team and to help influence, build, and mature our Artwork & labeling roadmap.  We are looking for a collaborative visionary leader that understands the value of working closely with “the business”. An individual with an appetite for industry “best in class” and the passion and leadership necessary to drive meaningful changes in how we improve our business operations. This position requires a motivated team player who can align with and support the ElevateBio’s business principles, mission, and objectives.

Essential Areas of Responsibility

  • Driving specific 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 for material labeling
  • Collaborate, develop, and maintain relationships with internal and external partners (including but not limited to Manufacturing, R&D, Regulatory Affairs, Quality, Supply Chain, artwork/labeling vendors, and clients) to deliver all artwork and packaging solutions
  • Act as the primary point of contact with suppliers and customers regarding artwork/labeling changes
  • Working with external clients & vendors to create label work proposals to support needed clinical and commercial activities. Ensure budget, PO creation, and invoice payments occur on time
  • Reviewing and approving packaging artwork for accuracy, regulatory and production requirements
  • Develop procedures and associated work instructions, forms, checklists, and other best practice tools required for an industry leading artwork service
  • Identifying opportunities for continuous improvement in label design deliverables and processes. Develop, lead, and implement projects and tools to achieve these improvements
  • Establish and manage ongoing metrics and KPI’s for labeling and packaging activities
  • Have clear knowledge and understanding of industry business practices for artwork and labeling change management

Education & Experience Requirements

  • Bachelors in life sciences, package engineering, or graphic design with 8+ years of experience
  • Knowledge of electronic label management software, CAPA, specification, change control, and project management systems preferred.
  • Strong understanding of FDA and other country Health Authority regulations and guidelines with the ability to interpret them.
  • Experienced with both clinical and marketed product labeling and patient information leaflet design.
  • 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.
  • Experience with ERP systems as they relate to labeling is a plus.
  • Excellent skills in electronic Quality Management Systems, Visio, Word, Excel, and PowerPoint
  • Ability to work both independently and effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
  • Ability to develop, implement and monitor a metrics performance package for labeling and packaging activities.
  • Excellent communication and influencing skills, strong collaboration skills.
  • Positive attitude and strong interpersonal skills required to effectively address problems and interface with other functional areas of the company while working in a matrixed global environment.

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases.  We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders.  With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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