Manufacturing Specialist II
Bluebird Bio, Durham, North Carolina, 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 supply at our internal bRT site. 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
- Provides technical support for the manufacture of a gene therapy product. Supports troubleshooting equipment-related issues and develops sound engineering solutions to address identified problems.
• Writes/revises standard operating procedures (SOPs), training documents (OJTs) and batch records (BPRs).
•Acts as system owner to support equipment qualification / re-qualification
• Leads deviation investigations to adequately identify the root cause and implements appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis, investigational tool, and methodologies.
• Identifies and implements continuous improvement projects to improve yield, reliability, and/or process robustness.
• Writes and implements change controls for the manufacturing area.
• Participate in tech transfer of new products into the facility.
• Provides training and technical development for the manufacturing team.
• Responsible for coordinating activities to support manufacturing (i.e. raw materials and BPR issuance) as needed.
• Ensures manufacturing goals are achieved through robust safety practices and quality compliance.
• Develops and maintains departmental metrics and key performance indicators (KPIs).
• Work closely with Manufacturing and Quality to continually improve all aspects of operations.
• Provide on-the-floor support during manufacturing operations.
WHAT YOU’LL BRING
- B.S. in engineering or life sciences, with 5+ year’s relevant industry experience. Advanced degrees desirable.
• Strong understanding of cGMPs is desirable.
• Experience with producing and purifying biologics and/or commercial biologics manufacturing is strongly
• Prior experience in quality investigations and deviation writing in a manufacturing environment is required.
• Manufacturing experience (upstream or downstream) and/or Validation experience is preferred.
• Must be able to work both independently and as part of a multi-disciplinary team.
• Excellent organizational skills enough to multi-task in an extremely fast-paced environment with changing
• Should be highly motivated, collaborative, and have excellent communication skills to influence across
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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