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
Join bluebird bio’s enthusiastic, collaborative team and contribute to the overall success of our novel gene therapy approach. We seek an energetic and goal-oriented candidate looking to become a Quality Control professional within the Quality Sciences and Analytical Technology team. This role will support analytical method validation and lifecycle activities for lentiviral vector material and/or autologous stem cell drug products. The candidate will interface with contract manufacturers, contract test organizations and internal manufacturing and analytical teams to support implementation and remediation of analytical methods used for the release of clinical and commercial Lentiviral Vectors and/or autologous stem cell drug products. The candidate should have experience in molecular and cell biology techniques including bioassays, ELISA, qPCR, Relative Potency Assays and flow cytometry. "• Lead QC laboratory studies performed for validation and/or remediation of QC methods used for in-process, release and stability testing of lentiviral vector material and/or autologous stem cell drug products
HOW YOU’LL FLY
- Review and approve method lifecycle documents such as protocols, reports and technical assessments required for the maintenance of the lifecycle for bioassay, molecular and/or cell-based methods used by the QC unit
- Lead analysis of data generated during method lifecycle activities using statistical software and/or Microsoft excel
- Own and/or support cGMP routine testing by owning quality systems required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
- Support method monitoring of bioassay, molecular and/or cell-based methods to support QC method lifecycle
- Communicate project status to cross-functional teams including QC, CMC and QA
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- BS/BA in Biology (or related discipline) with 4-5 years, Master with 2-3 years or PhD with 1-2 years of experience in a biotechnology discipline
- Must have extensive experience in Relative Potency Assays as well as experience in at least 1 of 3 methodologies ELISA, qPCR and flow cytometry
- Experience with development, qualification, validation and/or revalidation of methods to be used by the Quality Control unit is required
- Experience in a GMP environment, with the Quality Control unit is required
- Proficient with Microsoft Word, Excel, PowerPoint, statistical software (JMP or Prism)
- Experience with Parallelism Assessment with PLA software is a plus
- Strong initiative and scientific mindset that is motivated by analytical and operational challenges
- Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
- Passionate about working to critical unmet medical needs of patients
- Self-motivated and 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
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.