ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers, and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise-up and recode the science, the systems, and the status quo.
HOW YOU’LL FLY
The Oncology Technical Development & Operations team at bluebird bio operates with resolute focus to develop, manufacture and supply cell therapies to our patients. This is your chance to help deliver un-incremental change in this emerging field.
The focus of this position is to support Supply Chain within bluebird bio Oncology to enable the growing network of Clinical and Commercial Apheresis Collection Centers and Cell Therapy Labs. We are looking for an innovative professional with the breadth of experience and drive to implement our vision for this function and work collaboratively across bbb.
This role will provide both clinical and commercial sites pre-boarding and onboarding training, scheduled apheresis collections, and site monitoring support. As a headquarters-based and/or remote team member, you will be a part of several projects, cross-functionally collaborating with CMC, Non-clinical, Clinical, Manufacturing, QA, Supply-Chain, Commercial, and administrative areas. This position provides an excellent opportunity to gain experience and learn broad aspects of gene therapy regulations.
As an Oncology Technical Development & Operations bird reporting to Senior Director, Global Apheresis Operations, you'll help to bring more patients their bluebird days by:
- Working with the Director, Supply Chain, or designee, to oversee the administrative and operational aspects of apheresis collections and product development.
- Conductingclinical & commercial site onboarding activities including site training, scheduled apheresis collections, and site monitoring functions and as needed support.
- Partnering with quality during the quality audit to perform routine technical assessments at the clinical and/or commercial sites.
- Providing apheresis expertise to support various internal activities such as regulatory submissions, protocol development, and other quality processes.
- Partnering with clinical, quality, supply chain, and commercial teams to build a sustainable collection network for clinical trials and commercial operations.
- Working with commercial personnel to promote and coordinate commercial business plan
- Participating in clinical & commercial site qualification visits for training and method transfer.
- Working independently to ensure that contracted facility collection functions are current as to equipment, training, and technology according to internal procedures and recommendations.
- Contributing to the development and maintenance of procedures related to standard cell procurement and apheresis practices, within Apheresis Operations team.
- Providing technical feedback and guidance on optimizing collection procedures, or impact of collection procedures on further manufacturing.
- Working closely with the Supply Chain team to ensure traceability of apheresis product for clinical and commercial manufacturing.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have a BS/MS or RN degree/equivalent, with strong apheresis experience required (5+ years).
- Experience in Bone Marrow / Stem Cells Transplantation preferred.
- Willingness to travel, domestically and some internationally (~30% of time).
- Flexibility needed due to patients’ apheresis 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/EMA, AABB, FACT/JACIE, GMP, GCP, etc.)
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.