Scientist II, Bioassay Lead at bluebird bio, Inc. in Cambridge, Massachusetts

Job Description:

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 Method Development and Qualification (MDQ) 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. Come work with a talented, dedicated, and compassionate group of birds that loves rising to the challenge much as we do enjoy collaborating with a team of likeminded scientists!

HOW YOU'LL FLY

As a Scientist II bird reporting to a Director, Analytical Development, 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.
* 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.
* Supporting implementation of new platform technologies to increase analytical capabilities, plays a key role in improving processes and procedures.
* Communicating scientific data and concepts effectively through presentations, protocols, test methods and reports. May contribute 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 a Ph.D in Immunology, Virology, Cell Biology or related field with 4+ years of industry experience in bioanalytical method development, qualification, and validation.
* Are experienced in managing, mentoring, and training direct reports.
* Are familiar with CAR T/TCR-based cell therapies and the analytical methods for lot release and characterization as well as a strong background in T cell biology and T cell functional assays.
* Have expertise in developing cell-based potency assays e.g. reporter and protein expression assays to reflect mechanism of action of drug product candidates and relative potency determination, with good understanding of the statistical approaches.
* Are experienced in bringing and applying new technologies suitable for bioassay development such as cell line engineering, stable clone generation and cell banking.
* Have a strong technical knowledge in flow cytometry.
* Have experience and ability to use DOE for assay optimization and robustness and knowledge of relevant USP/ICH/EU regulations and GxP experience in a CMC group in analytical method development.

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..