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 and cell therapy approaches. bluebird bio seeks an experienced professional to lead the Cellular Process Development function. In this role you will have a leadership position within the Process and Analytical Development organization that encompasses viral vector, RNA, cell processing and analytical development for oncology. The position reports to the Vice President, Process and Analytical Development and leads a team of passionate scientists. This position is ideally suited for a professional with passion for and a proven track record of exceptional talent development and organizational leadership. There is a great opportunity to lead and evolve this function to support a broad portfolio and advance the innovations in cellular manufacturing capabilities to deliver therapies that transform the lives of patients. "Lead and develop technical functions to deliver scalable, robust manufacturing processes for our T-cell platforms, including development of integrated control strategies and implementation of technologies to drive innovations.
HOW YOU’LL FLY
- Develop and mentor a high-performing team of scientists and engineers with a vision of setting industry-leading scientific standards in cellular process development
- Drive the continued development of robust, cost-effective, scalable cellular manufacturing processes for bluebird bio’s oncology pipeline
- Apply biologics development and automated manufacturing concepts, tools, and practices while driving to re-define how they are applied in this novel and growing field
- Apply Quality by Design principles to develop a deep understanding of the manufacturing processes for genetically modified cells and to define robust, integrated control strategies
- Identify risks and drive continuous process improvement through technological innovation and alignment with regulatory and commercial manufacturing requirements
- Develop and implement Process Performance Qualification (PPQ) strategy and post-approval process improvements with effective balance among quality, financial, and inventory risks
- Build processes and strong relationships with external and internal manufacturing organizations
- Support regulatory strategy and activities, including authoring and review of CMC documentation for regulatory filings
- Act as a first-line resource to manage the interface between other CMC, Research, Clinical, Regulatory, and Program Management functions and to align the functional strategy with peer dependencies and with program, portfolio, and corporate goals
WHAT YOU’LL BRING
- A PhD in the pertinent life sciences or engineering, with 10+ years relevant industry experience
- Demonstrated experience leading a diverse technical organization as well as interfacing with external manufacturing providers, partners, and or academic collaborations.
- Prior experience in successfully managing manufacturing sciences or process development functions in complex biological processes and experience in cell therapy is a plus
- Proven track-record of successfully integrating activities and perspectives across functions
- Ability and track record of successfully supporting biologics programs through early- or late-stage clinical development is required.
- Technology transfer and extensive biologics technical experience is required.
- Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
- Outstanding communication, analytical and organizational skills
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- passion for addressing the critical unmet medical needs of patients
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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.