Manufacturing Specialist II
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 execute the manufacturing strategy for clinical and commercial vector, plasmid, and small molecule supply at bluebird’s contract manufacturing (CMO) partners. We are interested in candidates with a proven track-record in GMP manufacturing to help us achieve our goal of delivering therapies that transform the lives of patients.
HOW YOU’LL FLY
As a Manufacturing Specialist bird reporting to Director, Vector Manufacturing, you'll help to bring more patients their bluebird days by:
- Acting as a point of contact for a CMO and shares best practices among peers.
- Independently manage the review of batch records and in-process results and partner with Quality to complete deliverables required for disposition of batches.
- Proactively identify issues in the manufacturing process and solve them.
- Facilitating and own internal and external working team meetings.
- Proactively spot process improvements and suggest a plan and approach for new initiatives.
- Capable of serving as the primary Person in Plant for a CMO.
- Ensuring that all contractual obligations with our CMOs are met.
- Owning change controls, deviations, investigations, and CAPAs as necessary.
- Working closely with bluebird’s internal process development and MSAT groups to execute process characterization, technology transfer, and validation for commercial supply.
- Providing the technical expertise around manufacturing for technical reports and regulatory submissions.
- Generating, managing, evaluating, and maintaining critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed.
- Writing/revising SOPs and batch records as needed.
- Travel 10-25%
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- B.S. in engineering or life sciences, with 6+ year’s relevant industry experience. Advanced degrees desirable.
- Strong understanding of cGMPs is a must.
- Experience with producing and purifying biologics and/or commercial biologics manufacturing is strongly preferred.
- Highly organized and detailed oriented
- Experience with technology transfer or vendor management is preferred.
- Experience with process characterization and validation is a plus.
- Should be highly motivated, collaborative, and be able to multitask in a fast-paced environment with changing priorities.
- 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.
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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