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Director, Manufacturing at bluebird bio, Inc.

Posted in Other 30+ days ago.

Type: Full Time
Location: Durham, North Carolina





Job Description:

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

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Bluebird bio seeks a patient-focused leader as a Director, Manufacturing for our new facility in North Carolina's Research Triangle. As a single point of accountability for all aspects of Manufacturing of the site, you will have responsibilities for leading the execution of lentiviral vector (LVV), a critical starting material in our gene therapy platform. This role will focus on both technology transfer and routine (clinical and commercial) manufacturing. As part of the new facility startup and transition to routine operations, this individual will work with the cross-functional bluebird team, including Global Supply Chain, Quality Assurance, Quality Control, Facilities, Manufacturing, Manufacturing Sciences & Technology, Process Development, and Human Resources, to lead manufacturing operations. We seek candidates with proven ability to develop talent, successfully lead organizations, and drive cross-functional teamwork. 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. As the facility transitions from start-up to routine manufacturing, the role will be a key leader in implementing a cross-functional management system, focusing on identifying KPIs, tracking their performance on a daily basis, and rapidly taking action based upon that performance.

HOW YOU'LL FLY

*Through meaningful career development planning, challenging assignments, and ongoing coaching, invest in creating the next generation of leaders at bluebird bio.
* Establish systems and oversee operations related to GMP vector manufacturing at the site. The scope of manufacturing includes cell expansion, upstream, downstream and fill finish operations.
* SAFETY: In compliance with all state and local requirements, create a culture where potential safety hazards are identified/shared and effective actions are rapidly implemented. Drive a zero-injury mindset on the team.
* QUALITY: Embed the highest standards of compliance with our quality systems into the site's day to day activities; drive deviation reduction through effective problem solving and CAPA, ensuring that all quality systems documents are completed on or before their due dates
* SUPPLY: Develop and execute an overall manufacturing strategy to deliver on-time and in-full manufacturing and disposition of batches per the annual production plan.
* STRATEGY and COST: Successfully perform technology transfers consistent with bluebird bio's overall manufacturing strategy and achieve continuous process improvement.
* Represent bRT Site in internal and external Manufacturing forums and effectively communicate plans to bRT Site Leadership Team

WHAT YOU'LL BRING

* Bachelor's Degree in a scientific discipline with 15+ years of industry experience
* Must be skilled at and committed to the development of other team members
* Leadership experience in biologics manufacturing is a must, and experience with viral processing is a plus
* Strong understanding of operational discipline and cGMPs
* Experience with new facility start-ups and process technology transfers is preferred
* Experience with both clinical and or commercial manufacturing preferred
* Excellent organizational skills and ability to multitask in a fast-paced environment with changing priorities
* Excellent interpersonal, verbal and written communication skills and the ability to collaboratively influence at all levels of the organization
* Driven and self-motivated to lead and operate in a fast-paced, dynamic, and rapidly growing company environment with minimal direction
* Must be willing to have a flexible schedule to support 24 x 7 manufacturing activities. Travel is expected to be approximately 10%.


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..


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