Job Description
ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
This is a hands-on leadership role within our Quality Control stability team. We are looking for an experienced Quality Control professional to lead activities associated with QC strategic management of stability programs for ancillary materials, starting materials ,and drug products in support of our early and late-phase clinical and commercial development to ensure successful clinical and commercial regulatory filings in the US. You will provide significant contribution to the daily operations of the Quality Control, and partner with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network.
HOW YOU’LL FLY
You’ll help to bring more patients their bluebird days by:
- Contributing to the operation of stability programs across a multi-product portfolio
- Originating ICH compliant stability plans, protocols, and reports; coordinate, review, trend, and report stability test data for drug product
- Overseeing the maintenance of stability sample inventory, performance of stability sample pulls, and sample submissions to test laboratories
- Managing and documenting stability test schedules and tracking of pending data for the purpose of maintaining performance of program metrics
- Collecting raw data from test labs, performing cGMP data review, collating and archiving; utilizing statistical software to trend analytical data associated with stability testing
- Leading and/or collaborating with Quality, internal functional areas, and/or CxOs, to review and perform documentation of deviations, CAPAs and OOS/OOT investigation reports
- Providing data verification for CMC stability section of regulatory filings.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- Bachelor’s degree in a scientific discipline, 5+ years of related experience in a QC GMP environment
- Strong knowledge of cGMP/ICH/FDA/EU stability regulations
- Solid understanding of statistical analysis as it relates to product stability trending and establishment of shelf life
- Experience and strong understanding of statistical software packages such as JMP
- Ability to foster open communication, and facilitate mutual understanding and cooperation across various teams
- Ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities
- Experience with CTO/CMO management and strong interpersonal skills with the ability to motivate others, influence, and negotiate challenging situations
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.
Date Posted
02/03/2023
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5
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