Engineer, Packaging & Labeling

Location
Cambridge, MA, United States
Posted
Dec 07, 2018
Ref
967157
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative flock and fly at the cutting edge of science. Contribute to the overall success of our novel gene therapy approach and make a transformative impact in the lives of patients with severe genetic and rare diseases.

bluebird bio seeks an entrepreneurial and highly motivated packaging and labeling professional with broad experience and expertise developing and implementing packaging and labeling solutions for our clinical and commercial products. This position works closely with internal Regulatory, Clinical and Commercial teams as well as our network of external manufacturers and suppliers to define and implement artwork, labeling, and packaging solutions for our products that are compliant with industry standards and regulations. Additionally, this position will define and implement robust processes and procedures for developing and managing artwork and labeling and lead efforts to align and optimize primary and secondary packaging solutions based on operational requirements.

Responsibilities (included but not limited to):
  • Lead qualification activities for all shipping systems utilized for the shipment of temperature-controlled materials
  • Manage relationship with Cold Chain and Packaging vendors to assure fulfillment of bluebird bio products
  • Communicate with Regulatory Affairs to ensure all packaging and labeling requirements are met and all data and/or specifications are provided for regulatory filings
  • Coordinate internal and external packaging resources and ensure packaging projects are appropriately resourced for meeting project deadlines
  • Lead the design, development, implementation, and maintenance of primary, secondary and tertiary packaging for viral and cell therapy products and intermediates
  • Lead development of packaging User Requirement Specification (URS) documents in close coordination with key internal stakeholders
  • Provide oversight of packaging and labeling activities at internal and external manufacturers/CMOs
  • Improve upon area related SOP's and work instructions ensuring compliance with GDP's, cGMP's, and country specific regulations related to Cold Chain and Packaging
  • Support maintenance of metrics on Cold Chain, Transportation/Logistics operations
  • Through collaboration with Artwork & Labeling Manager, Regulatory, Clinical, and Commercial teams, integrate regulatory, technical, and branding requirements into the design of compliant Cell Collection, Drug Product labels used for domestic and international clinical trials and commercial markets
  • Through use of external vendors, facilitate the accurate translation of labels and PIL (as required)
  • Support the integration and deployment of Cell Collection and Drug Product labels via bluebird bio product traceability system at clinical and commercial collection centers and external manufacturers
  • Lead change management processes for labeling, including the development or revision of Label Specifications & Label Proofs
  • Support the incorporation of labeling requirements into projects to evaluate and optimize primary and secondary packaging solutions based on manufacturing and operational requirements
  • As required, identify, assess, and implement the use of external artwork design and print vendors to optimize design and implementation of labels and proofs
  • Support Artwork & Labeling Manager in selecting and implementing labeling stock at various bluebird bio CMO's


Preferred Qualifications & Experience:
  • BS degree in Engineering or Packaging Science
  • 3+ years of relevant Packaging/Cold Chain Management experience within the Biotech/Medical Device/Pharmaceutical Industry
  • Experience in a GMP environment required
  • Experience working with CMOs desirable
  • Proactive in approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution
  • Excellent MS Office and MS Project skills
  • Ability to work on multiple projects simultaneously
  • Effective analytical skills with demonstrated success in problem solving
  • Excellent communication, organizational, and customer service skills are a necessity
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Passion for simplification, quality and process improvement
  • Comfortable operating in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Ready and excited to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself