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
The Analytical Development flock is all about working collaboratively. Whether it’s making sure our analytics are accurate and precise, developing state of the art single cell assays, or compiling data for regulatory submissions, we are driven by a genuine desire to provide superior understanding of our drug product attributes. Our product development is dynamic and complex, and successful regulatory filings hinge on showing analytical comparability. Come lead our late-stage product comparability effort and work with a dynamic group of birds that loves rising to the challenge of commercializing gene therapy products.
HOW YOU'LL FLY
As a Senior Scientist bird reporting to the Director of Analytical Development, you'll help to bring more patients their bluebird days by:
- Leading product comparability design, execution and analysis
- Authoring comparability protocols and reports
- Interfacing with analytical product leads, regulatory leads, process development leads, and statisticians
- Driving knowledge management by collecting, maintaining, and analyzing relevant data sets for enhanced product understanding
- Fulfilling attribute data requests from CMC, Clinical, and Bioinformatics functions. Managing product attribute data transfer and data verification requests
- Authoring regulatory submissions
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- PhD and 4+ years or Master’s and 8+ years of biotechnology experience in early or late stage drug development
- Demonstrated ability to lead comparability studies
- Knowledge of JMP software
- Excellent technical writing skills and track record of authoring successful regulatory submissions preferred (briefing books, INDs, MAA, BLA)
- Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional project teams
- Familiarity with Quality by Design approaches in drug product development and experience managing and visualizing large or complex data sets
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.