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 approach. We seek an energetic and goal-oriented candidate looking to join a cross-functional quality control team dedicated to This indivthe implementation and maintenance of analytical methods supporting raw materials, starting materials, and several other aspects related to gene therapy products. idual will be responsible for oversight of raw materials procedures, method verification/validation, technical writing of Quality Control protocols, reports, and analytical procedures. A candidate with technical experience with bioassay, molecular biology, ELISA, HPLC, wet chemistry would be ideal for this role.
HOW YOU’LL FLY
As a Quality Control bird, you'll help to bring more patients their bluebird days by:
- Author/Review procedures, protocols and reports
- Developing, verifying, validating analytical test methods to support raw materials testing at external contract labs (i.e HPLC, GC, ELISA, wet chemistry)
- Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification
- Collaborate internally and externally to support the implementation of analytical methods and support life cycle management
- Experience with method transfer, qualification, and validation (preferred)
- Experience with data trending, including use of statistics to monitor method performance
- Work with procurement team to process contracts and purchase orders
- Manage the shipping and receiving of materials
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Strong QC/cGMP knowledge and experience with 5+ years’ experience working in a pharmaceutical or biotechnology firm
- Preferred knowledge of ICH guidelines, USP, EP, and JP monographs
- Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
- Motivated by technical and scientific challenges
- Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and
cooperation between all stakeholders
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.