Apheresis Nurse Expert
About the role:
- Work with the Director, Apheresis Operations, or designee, to oversee the administrative and operational aspects of apheresis, bone marrow, and whole blood collections and product development.
- Manage group of Apheresis Consultants and coordinate their activities as needed to support internal and external apheresis network demands.
- Oversee operational and administrative functions of apheresis consultant network for schedules, payroll, and reporting/documentation of site visits
- Partner with clinical, quality, and commercial teams to help build a sustainable collection network for clinical development and commercial operations.
- Conduct clinical & commercial site onboarding activities including site training, scheduled apheresis collections, and site monitoring functions.
- Participate in clinical & commercial site qualification visits for training and method transfer.
- Conduct periodic assessments of collection facilities as needed.
- 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.
- Partner with clinical, quality, and commercial teams to build a sustainable collection network for clinical trials and for commercial operations.
- Provide technical feedback and guidance on optimizing collection procedures, or impact of collection procedures on further manufacturing.
- Provide apheresis expertise to support various internal activities such as regulatory submissions, protocol development, and other quality processes.
- Work closely with the Supply Chain department to ensure traceability of whole blood and apheresis product for clinical manufacturing.
- BS/MS or RN degree with 10 years of experience in a relevant medical field.
- 10 years of apheresis experience required.
- Willingness to travel, domestically and internationally (~30% of time)
- Flexibility needed; some weekend work possible 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 (AABB, FACT JACIE)
- Good understanding of GMPs, GLPs, and GCPs
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself