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 Quality Control flock is all about collaborative teamwork contributing to the overall success of our novel gene therapy approach. Whether it’s supporting and establishing new commercial-level in-house GMP testing laboratories or performing analytical methods, data review and trending, implementation of GMP operational support systems ensuring a compliant Quality Control lab, we are driven by our patients. Come work with our flockin' awesome group of birds that loves rising to the challenge!
HOW YOU’LL FLY
As a Quality Control bird you'll help to bring more patients their bluebird days by:
- Leading cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, and ELISA)
- Authoring, reviewing, and/or approving SOPs/policies and technical reports with general guidance
- Helping to review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization
- Working with (these teams) to accomplish (a specific goal)
- Successfully lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
- Lead and support CAPA/Continuous Improvement Initiatives
- Execute phase-appropriate test method validation protocols as needed
- Participate in providing the necessary information for regulatory filings and inspections.
- Act as manager designee for quality document review and approval, as applicable
- Implement, lead and/or support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
- This position will require hands on laboratory time.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have a BS with 7+ years or MS with 4+ years in a cGMP/GxP environment preferred
- Are experienced in in flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
- Demonstrate a strong initiative and scientific leadership
- Direct experience in authoring and review/approval of SOPs
- Are familiar with (tools or programs that will be used frequently)
- Have 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
Applicant must be flexible to work the following shifts and meet business needs:
- Eight-hour shifts
- Four ten-hour shifts followed by three days off (Sunday-Wednesday 1pm-11:30pm)
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.