Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks a patient-focused leader as a Manufacturing Supervisor for our new facility in North Carolina’s Research Triangle. As a single point of accountability for all aspects of an area’s shift operations, you will have responsibilities for leading the execution of lentiviral vector (LVV) manufacturing, a critical starting material in our gene therapy platform. We seek candidates with proven ability to organize, manage, and continuously improve the manufacturing operations process. You will be directly responsible for a team of Manufacturing Associates processing in upstream, downstream and aseptic fill/finish. Specifically, we are looking for a leader with a track record of building a safety culture, driving the highest standards of a quality mindset, and ensuring uninterrupted supply for patients.
About the role:
- Through meaningful career development planning, challenging assignments, and ongoing coaching, invest in creating the next generation of leaders at bluebird bio.
- This is a hands-on position requiring consistent physical presence on the manufacturing floor to enable training and mentor-ship of team, troubleshooting, and development of process improvements.
- Establish systems and oversee operations related to GMP vector manufacturing at the site.
- SAFETY: In compliance with all state and local requirements, identify potential safety hazards and rapidly implement effective actions; Drive a zero-injury and environmental responsible mindset on the team
- QUALITY: Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities; lead investigations as related to the manufacturing process. Author deviations, and CAPAs as required. Partner with Quality to address issues effectively and compliantly.
- SUPPLY: Develop daily shift schedules and oversee all aspects of execution to deliver on-time and in-full manufacturing and disposition of batches. Ensure documentation (batch records and SOPs) are accurate and updated as required.
- STRATEGY and COST: Successfully perform technology transfers consistent with bluebird bio’s overall manufacturing strategy and achieve continuous process improvement.
- BS in a scientific discipline with 5+ years of industry experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, purification (clarification, chromatography, TFF,), aseptic fill/finish
- Demonstrated ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
- Strong understanding of operational discipline, FDA regulations and cGMPs
- Experience with new facility startups and process technology transfers is preferred.
- Experience with both commercial and clinical manufacturing is preferred.
- Should have excellent organizational skills and be able to multitask in a fast-paced environment with changing priorities.
- Must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be approximately 10%.
- Excellent communication skills and ability to influence across multiple functions.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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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