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.
Quality Control Analyst (Contract)
This role is for a 12-month contract position.
ABOUT THE FLOCK
The Quality Control flock is all about getting stuff done and working collaboratively. Whether it’s making sure we’re supporting establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products, working collaboratively across the nest, or driving innovation as a unit, we are driven by effective communication, critical thinking, and the ability to ask questions while supporting one another. Come work with an energetic and enthusiastic group of birds that loves rising to the challenge much as we do!
HOW YOU’LL FLY
As a Quality Control Analyst bird reporting to David Demeusy, you'll help to bring more patients their bluebird days by:
- Performing cGMP analytical testing (bioassays, flow cytometry, qPCR, HPLC, and ELISA)
- Reviewing and evaluating raw data from a peer or technical review level of all analytical methods, as well as sample authorization
- Author, review, and/or approve SOPs/policies and technical reports with general guidance
- Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
- Lead, author, perform, review, and/or approve equipment validations with minimal guidance
- 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)
- 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
- Other related tasks as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- BS with 4+ years in a biotechnology discipline
- 4+ years of experience in a cGMP/GxP environment is preferred
- Preferable hands on experience in cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA
- 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
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.