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
Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks a patient-focused leader as a Manufacturing Associate for our new facility in North Carolina’s Research Triangle. You will have responsibilities for executing all process steps in the manufacture of lentiviral vector (LVV), a critical starting material in our gene therapy platform. This role will focus on both the facility startup, new product technology transfers and routine (clinical and commercial) manufacturing. As part of new facility design, construction, startup, and transition to routine operations, this individual will work with the cross-functional bluebird team, including Quality Assurance, Quality Control, Facilities, Manufacturing Sciences & Technology, and Process Development to lead day-to-day operations. We seek candidates with proven ability to work in a GMP environment. Specifically, we are looking for team members with track records of building a safety culture, driving the highest standards of a quality mindset, and ensuring uninterrupted supply for patients. As the facility transitions from a capital project to routine manufacturing, the role will be at the center of implementing a cross-functional management system, focusing on identifying KPIs, tracking their performance on a daily basis, and rapidly taking action based upon that performance
HOW YOU’LL FLY
Through meaningful career development planning, challenging assignments, and ongoing coaching, invest in creating the next generation of leaders at bluebird bio.
• Establish systems and oversee operations related to GMP vector manufacturing at the site. The scope of manufacturing includes upstream or downstream operations.
• SAFETY: In compliance with all state and local requirements, identify potential safety hazards and rapidly implement effective actions; Drive a zero-injury mindset on the team
• QUALITY: Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities; author/update procedures to ensure that activities can be executed Right First Time; strictly comply with all written procedures
• SUPPLY: Follow daily shift schedules and execute all aspects of the process from media/buffer preparation, vial thaw, cell culture, purification, and final aseptic filling.
• STRATEGY and COST: Successfully execute technology transfers consistent with bluebird bio’s overall manufacturing strategy and achieve continuous process improvement through waste reduction and error proofing.
WHAT YOU’LL BRING
• BS in a scientific discipline with 3+ years of industry experience.
•Must be skilled at and committed to the development of other team members
• Hands-on experience in biologics manufacturing is a must, and experience with viral processing is a plus
• Strong understanding of operational discipline and cGMPs
• Experience with new facility startups and process technology transfers is preferred.
• Should have excellent organizational skills and be able to multitask in a fast-paced environment with changing priorities.
• This role will be a day-shift position during start-up. However, you must be willing to have a flexible schedule to support 24x7 manufacturing activities. Excellent communication skills and ability to influence across multiple functions.
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.