Manager, Analytical Operations
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
The Analytical Operations (AO) flock is all about working collaboratively and getting the stuff done. Whether it’s testing samples to support our partner teams, lifecycle management of methods, or supporting tech transfers and investigations, we are driven by the ultimate goal of delivering therapies that transform the lives of patients. Come work with a talented, dedicated, and compassionate group of birds that loves rising to the challenge much as we do enjoy collaborating with a team of likeminded scientists!
HOW YOU’LL FLY
As an AO manager reporting to Head of Analytical Development, you'll help to bring more patients their bluebird days by:
- Leading a vector analytics team focused on providing testing support for process development, research and manufacturing
- Leading the method lifecycle management team for vector analytics
- Performing method pre-qualification and qualification, authoring analytical test methods/qualification protocols, development, and qualification reports
- Developing and qualifying ELISA-based methods for in-process and residual testing
- Working with the process development and manufacturing teams in support of in-process testing and investigations and collaborating closely with the quality control groups to support characterization, method optimization, troubleshoot, transfer and validation
- Mentor and manage daily activities, provide technical leadership and manage multiple projects
- Supporting implementation of new platform technologies to increase analytical capabilities and efficiencies, play a key role in improving processes and procedures
- Ensure proper data verification and trending
- Goal setting and managing projects to timelines
- Manage external CTO partners and assess opportunities for bringing work in-house
- Communicate test results effectively through presentations, protocols, test methods and reports
WHAT YOU’LL BRING
- Have a Ph.D in Biochemistry, Molecular or Cellular Biology or related field and 4 + years industry experience or Masters Degree and 8 + years’ experience in analytical operations, quality control testing or method development
- Strong operational background and track record for delivering high quality analytical results on tight timelines
- Are experienced in managing, mentoring, and training direct reports
- Are familiar with vectors used in CAR T/TCR-based cell therapies and gene editing, and the analytical methods for lot release and characterization
- Background in T cell biology and T cell functional assays helpful
- Have excellent organizational, analytical, communication and scientific writing skills
- Are a highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Have knowledge of relevant USP/ICH/EU regulations and GxP experience in a CMC group in analytical operations
- Method automation experience helpful
- Are a creative thinker with ability to adapt to a fast-paced and ever-changing environment, thrive in a cross-functional environment and drive projects to successful outcomes
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.
Slack's cloud-based collaboration tools and services are used worldwide.