QC Cell Culture / Bioassay Analyst at bluebird bio, Inc. in Durham, North Carolina

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 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 QC Biochemistry and Bioassay flock is all about working collaboratively to support the success of bluebird bio's novel gene therapies. Whether it's performing release and stability testing for our products, supporting method validation and transfer activities, or ensuring a compliant QC laboratory, we are driven by teamwork and positivity to support our patients. Come work with an enthusiastic and dedicated group of birds that loves rising to the challenge much as we do!

HOW YOU'LL FLY

\\"* Perform cGMP analytical testing (potency assay, cell culture, qPCR, ELISA, and compendial testing methods)
* Review and evaluate raw data from a peer or technical review level of all analytical methods
* Author, review, and/or approve SOPs/policies and technical reports with general guidance
* Participate in laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
* Perform laboratory equipment maintenance with minimal guidance
* Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
* Execute phase-appropriate test method validation protocols as needed
* Participate in providing the necessary information for regulatory filings and inspections
* Lead and support CAPA/Continuous Improvement Initiatives\\"

WHAT YOU'LL BRING

\\"* Minimum BS in Biochemistry, Biology, Microbiology, Chemistry or other related field
* 3+ years of experience in a cGMP/GxP environment is preferred
* Hands on experience in aseptic technique, mammalian cell culture, quantitative PCR, and other bioanalytical methods such as ELISA, environmental and utility monitoring
* Demonstrate a strong initiative and scientific leadership
* Superb organizational, analytical, and communications skills and \\"do-what-it-takes\\" attitude
* A passion for addressing the critical unmet medical needs of patients
* Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
* Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
* During initial start-up activities travel may be required and the ability to work alternate shifts\\"

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.

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