Labeling / Packaging Supply Chain -Contractor bluebird bio – Cambridge, MA, USA
We seek an entrepreneurial and highly motivated labeling and packaging professional with broad experience and expertise developing and implementing labeling and packaging 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.
About the role:
- Through collaboration with 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 the use of external vendors, facilitate the accurate translation of labels (as required).
- Revise, define and implement processes, policies, and standard operating procedures for the development, implementation, and management of artworks and labels.
- Support the integration and deployment of Cell Collection and Drug Product labels via bluebird bio product traceability system at clinical and commercial collection site and external manufacturers.
- Define and support labeling requirements and processes for external raw material, drug substance, and drug product manufacturers.
- Support packaging and labeling requirements for clinical and regulatory submissions and filings.
- Lead change management processes for packaging and labeling, including the development or revision of Label Specifications and Label Proofs.
- Continuously assess and align artwork and labeling to current industry standards (FACT / JACIE) and appropriate regulations.
- Lead initiatives to simplify and improve label development and implementation processes.
- Lead and support Supply Chain 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.
- Bachelor’s Degree or equivalent
- 8+ years of Artwork / Labeling or Regulatory experience in the pharmaceutical, biotechnology industry (Cellular and Gene Therapy preferred)
- Proficient in the design, implementation and management of artwork and labeling for clinical and commercial products globally.
- Expertise in FACT / JACIE standards, FDA, EMA regulatory labeling requirements
- Experience in developing processes and standard operating procedures.
- Experience in use of label design tools / applications. Oversight of external artwork design and printing vendors a plus
- In depth knowledge of cold chain packaging requirements and design
- 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