About the role:
- Work with the Director, Apheresis Operations, or designee, to oversee the administrative and operational aspects of apheresis collections and product development.
- Conduct clinical & commercial site onboarding activities including site training, scheduled apheresis collections, and site monitoring functions.
- Partner with quality during the quality audit to perform routine technical assessments at the clinical and/or commercial sites.
- Provide apheresis expertise to support various internal activities such as regulatory submissions, protocol development, and other quality processes.
- Partner with clinical, quality, supply chain, and commercial teams to build a sustainable collection network for clinical trials and commercial operations.
- Work with commercial personnel to promote and coordinate commercial business plan
- Participate in clinical & commercial site qualification visits for training and method transfer.
- Work independently to ensure that contracted facility collection functions are current as to equipment, training and technology according to internal procedures and recommendations.
- Contribute to the development and maintenance of procedures related to standard cell procurement and apheresis practices, within Apheresis Operations team.
- Provide technical feedback and guidance on optimizing collection procedures, or impact of collection procedures on further manufacturing.
- Work closely with the Supply Chain department to ensure traceability of apheresis product for clinical and commercial manufacturing.
- RN degree/equivalent, with strong of apheresis experience required (5+ years).
- Experience in Bone Marrow / Stem Cells Transplantation preferred.
- Fluent English and addition languages would be an advantage.
- Willingness to travel, domestically and internationally (~50% of time)
- Flexibility needed due to collection schedules
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
- Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
- Independently motivated, detail oriented and good problem-solving ability
- Good understanding of applicable regulations and standards (FDA, AABB, FACT JACIE, Good Manufacturing Practices, etc.)
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.