Analyst, Quality Control
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Analyst, Quality Control, Method Monitoring and Critical Reagent
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 Quality Control flock is all about collaboration and support. Whether it’s interfacing with internal and external QC laboratories, leading the selection, creation, qualification, and implementation of critical reagents and reference standards across a global network of quality control laboratories and we are driven by our ability to contribute to the overall success of our novel gene therapy approach! Come work with this driven and innovative group of birds that love rising to the challenge!
HOW YOU’LL FLY
As a Quality Control bird reporting to our Method Validation manager, you'll help to bring more patients their bluebird days by:
- Leading and supporting quarterly assay trending and invalid assay summary reports
- Driving, authoring, and reviewing internal and external protocols and reports for the qualification and re-evaluation of critical reagents
- Helping to support cross-functional teams to identify and qualify reference standards in support of early, late, and commercial phase products (plasmid, LVV, and Drug Product).
- Working with our internal QC lab as well as external contract test organizations for the qualification, reevaluation, implementation, and inventory control of critical reagents
- Successfully ensuring the team has robust process for supporting the management and shipment of critical reagents to internal and external contract test labs
- Supporting cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, as well as laboratory investigations related to method performance.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have BS with 2+ years or an MS with 1+ years in a biotechnology discipline and in an industry setting (3+ years of experience in a GMP/GxP environment is preferred)
- Are experienced in cell-based bioassays (such as potency assays), molecular biology (such as qPCR), ELISA, and/or biochemistry
- Are familiar with statistical analyses of complex data sets
- Have excellent initiative and scientific mindset
- Self-motivated and the ability to work with limited direction in a fast-paced, goal-oriented environment driven by a passion for addressing the critical unmet medical needs of patients
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.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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