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
The Manufacturing Specialist will play an integral role in the collaborative management of third party CMOs to commercial Zynteglo and Skysona products. Managing the external manufacturing network is a critical component of bluebird's supply strategy, ensuring that the company effectively and efficiently delivers medicines to patients. The Manufacturing Specialist will work cross-functionally to provide manufacturing and technical support facilitation CMO issue resolution, deviation/investigation closure, and product disposition. Additional responsibilities will include assistance with tech transfer activities, to ensure accurate and compliant execution of the filed process. Furthermore, this role will support the initiation, assessment, and progression of change controls to support manufacturing bluebird bio products. Lastly, this position liaises with internal and external teams at bluebird bio CMO's in support of manufacturing activities.
HOW YOU'LL FLY
You'll help to bring patients and their families more bluebird days by:
- Work with the manufacturing operations team to support GMP production at CMOs. This will include Person-in-Plant activities.
- Leading the initiation, assessment and progression of change controls to support manufacturing bluebird bio's products.
- Authoring quality system documentation to allow for GMP-grade material release – including change controls and associated deviations, investigations, and CAPAs.
- Performing technical review of batch records and supporting data in collaboration with QA and QC for batch release
- Leading and/or participating in cross-functional operational meetings to ensure on-time release of GMP-grade material.
- Acting as a liaison with Supply Chain to ensure raw material supplies meet demand needs.
- Generating, managing, evaluating, and maintaining critical data in a highly organized manner.
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- BS in biological sciences or (bio)chemical engineering with 3+ years of experience in the industry, ideally within late phase or commercial manufacturing
- Experience in technical/process development and process/technology transfer as well as GMP manufacturing operations.
- Experience interacting with CMOs and managing production activities.
- Technical understanding of biopharmaceutical production. Experience in cell and gene therapy a plus.
- Excellent communication skills and ability to influence across multiple functions.
- Knowledge of aseptic processing and manufacturing
There is a hybrid preference for this role (Somerville, MA) however remote applicants within the US will also be considered. Travel to TX will be required.
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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