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 7 countries with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our flock 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 innovation and passion. We are looking for a scientist with the breadth of experience and drive to serve as leader and point person for understanding drug product quality attributes in support of cerebral adrenoleukodystropy, b-thalassemia, and sickle cell disease late-stage clinical and commercial programs. We are interested in candidates with a proven track-record of technical excellence in analytical or process development, experience in the application of Quality by Design principles to complex biologics, cell or gene therapies, and the ability to analyze complex data sets to develop understanding of factors that impact product quality. Come work with a dynamic group of birds that loves rising to the challenge much as we love working towards delivering therapies that transform the lives of patients!
HOW YOU’LL FLY
As an Attribute Scientist bird reporting to the Associate Director, Analytical Development you'll help to bring more patients their bluebird days by:
- Driving knowledge management by collecting, maintaining and analyzing relevant data sets for enhanced product understanding and being the point person for fulfilling data requests from CMC, Clinical, and Bioinformatics functions
- Managing product attribute data transfer and data verification requests as well as supporting the enhancement of product characterization in defining and addressing knowledge gaps
- Developing and maintaining deep understanding of product attributes:
- Impact of manufacturing process parameters on product attributes
- Understanding of correlations between attributes
- Relationship of product attributes to clinical outcomes
- Leading Comparability study design, execution and analysis and representing AD in CQA assessment activities
- Understanding strengths and limitations of analytical methods used to evaluate product attributes while serving as a product attributes subject matter expert within AD
- Providing technical support for complex process or product impact investigations
- Authoring regulatory submissions as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have PhD/MS with 3+/8+ years of industry experience in early or late stage drug development, preferably in cell-based gene therapy
- Have hands-on experience in analytical development and/or process development
- Are experienced in managing and visualizing large or complex data sets and applying statistical analyses
- Possess excellent technical writing skills with a track record of authoring successful regulatory submissions preferred (comparability studies, briefing books, INDs, MAA, BLA)
- Have experience in application of risk-based decision making and familiarity with quality by design approaches
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.