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 and getting the stuff done. Whether it’s making sure to develop and qualify high quality methods, authoring relevant documents, or support method transfers, we are driven by the ultimate goal of delivering therapies that transform the lives of patients. This highly technical leadership role will be Oncology-focused and will involve analytical method development, qualification and validation. Come work with a dedicated and compassionate group of birds that loves rising to the challenge much as we love moving science forward for patients!
HOW YOU'LL FLY
As a Senior Scientist, you'll help to bring more patients their bluebird days by:
- Leading a small group of Associate Scientists, mentoring/managing their daily activities, providing technical leadership and managing multiple projects in the Oncology space
- Driving the development and optimization of phase-appropriate cell-based potency (expression and MOA) and other functional bioassays that are used for in-process and final product lot release and stability testing as well as characterization studies for LVV-based gene and cell (CAR T/TCR) therapy programs
- Performing method pre-qualification and qualification/validation, authoring analytical test methods/qualification protocols, development and qualification reports
- Contributing to the writing and review of regulatory submissions
- Working with the process development and manufacturing teams in support of in-process testing and investigations and collaborating closely with the quality control groups to support characterization, method development/optimization, troubleshoot, transfer and validation
WHAT YOU'LL BRING
You’re the bird we’re looking for if you have:
- Ph.D in Immunology, Virology, Cell Biology or related with 6+ years of industry experience in bioanalytical method development, qualification, and validation
- Experience with CAR T/TCR-based cell therapies as well as a strong background in T cell biology and T cell functional assays
- Expertise in developing cell-based potency assays
- Strong technical knowledge in flow cytometry
- Knowledge of relevant USP/ICH/EU regulations and GxP experience in a CMC group
- Experience leading and mentoring direct reports
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.