Associate Director, Vector 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
For birds on our manufacturing team, patients and their families are counting on us to deliver for them, especially when it matters most. Come fly with us, this is your chance to help deliver un-incremental change in the emerging field of cell and gene therapy.
bluebird bio seeks an entrepreneurial manufacturing professional to lead a cross-functional team responsible for supply from our external manufacturing partners (contract manufacturers, CMOs). Collaborating closely with Quality, Process Development, Manufacturing Sciences and Technology, and Supply Chain, we are seeking a patient-focused leader with a strong technical background and a proven track-record of meeting quality, supply, and cost commitments for clinical and commercial products.
HOW YOU’LL FLY
As an Associate Director, Vector Manufacturing bird reporting to Vice President, Vector Manufacturing, you'll help to bring more patients their bluebird days by:
- Single point of accountability for all aspects of performance (Quality, Supply, and Cost) at bluebird’s designated CMO(s)
- Directly responsible for batch execution and relationship management as a peer to the CMO site head
- Establishing the strategy and priorities for the cross-functional team and execute to ensure a best-in-class patient experience (including uninterrupted supply and rapid cycle times)
- Attracting, retaining, and developing a team of direct reports to build a high-performing team, with the ability to effectively collaborate with partners remotely.
- Monitoring overall CMO performance, proactively identify risks, and implement actions to reduce the overall risk profile
- Driving a continuous improvement mindset, through proactive process monitoring, rapid troubleshooting, effective CAPAs, and proactive process improvements to strengthen quality compliance, enhance process robustness, and reduce COGS
- Ensuring that technology transfers and process validations are executed Right First Time
- Ensuring positive regulatory inspection outcomes through strong sponsorship of inspection readiness activities and direct interactions with health authorities
- Travel 10-20%
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have a passion for addressing the critical unmet medical needs of patients
- Experience leading a team responsible for overseeing GMP manufacturing for biologics; Prior experience with aseptic processing is a plus.
- An unwavering commitment to the highest standards of quality compliance
- Experience playing key roles in technology transfers for new processes and process monitoring/troubleshooting for existing processes
- Ability to collaborate cross-functionally, meet deadlines, and prioritize work in a dynamic environment
- Advanced verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
- Strong collaborative interpersonal skills with the ability to motivate others, influence, and resolve conflict situations
- A B.S. in the relevant life sciences or engineering, with 10+ years relevant industry experience. (Advanced degrees are very much desirable)
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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