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 and commercial programs in the exciting field of Cell & Gene Therapy. 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 the Manager of Drug Product Manufacturing, reporting to Director of Manufacturing, you will be managing more than one late-phase program. Drive the development and execution of projects within the CMO network (potentially including tech transfers, PPQ campaigns, regulatory inspections (inspection readiness activities) and post-approval changes) through effective use of project management & OE tools
- Working with the manufacturing operations team to support GMP production at CMO partners.
- Own and drive quality systems (change control, deviation, CAPA) as needed
- Providing the technical manufacturing expertise for technical reports and regulatory submissions.
- Writing/revising SOPs and batch records (as needed)
- Drive continuous improvement and operational excellence culture
- Travel 10-25%
WHAT YOU’LL BRING
- Degree in Engineering or Life Sciences, BS/8+ or MS/6+ years of relevant industry experience
- Strong understanding of cGMPs
- Experience with commercial biologics manufacturing experience is strongly preferred
- Highly organized and detailed oriented
- Must be able to work both independently and as part of a multi-disciplinary team.
- Excellent communication skills and ability to influence across multiple functions.
- 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.