Project Manager, Drug Product Manufacturing
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
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 Drug Product Manufacturing
team is all about working towards delivering for patients and their families! We’re seeking an entrepreneurial manufacturing professional to help develop and execute the manufacturing strategy for all clinical development programs, as well as commercial supply. This role encompasses day-to-day management of manufacturing deliverables in support of a broad portfolio of therapies. If you have a proven track-record of successfully integrating activities and perspectives across functions, come fly with us to help achieve our goal to deliver therapies that transform the lives of patients!
HOW YOU’LL FLY
As a Project Manager, Drug Product Manufacturing bird reporting to a Senior Director, Vector Manufacturing, you'll help to bring more patients their bluebird days by:
- Working with the manufacturing operations team to support GMP production at CMO partners.
- Developing and utilizing systems to track manufacturing deliverables including deviations, CAPAs, and change controls
- Ensuring on-time manufacturing and batch disposition
- Working with internal stakeholders to ensure on-time completion of actions.
- Providing the technical manufacturing expertise for technical reports and regulatory submissions.
- Writing/revising SOPs and batch records (as needed)
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- Degree in Engineering or Life Sciences, BS/8+ or MS/6+ years of relevant industry experience
- Commercial launch experience
- Strong understanding of cGMPs
- Experience with producing and purifying biologics and/or commercial biologics manufacturing
- Experience with technology transfer/vendor management and process characterization/validation (preferred)
*10-20% travel anticipated*
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.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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