Uncubed
   

Associate Director, Operational Excellence & Project Management

Bluebird Bio, Durham, North Carolina, United States

integrated product platforms with broad therapeutic potential


On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

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 and contribute to the overall success of our novel gene therapy approaches. bluebird bio seeks an Operational Excellence & Project Management leader at our new manufacturing facility, bluebird Research Triangle (bRT), in North Carolina. The 125,000 square foot facility will produce lentiviral vector for our gene and cell therapies, including treatments for multiple myeloma, transfusion-dependent Beta-thalassemia and sickle cell disease. The site is large enough to accommodate significant potential future expansion. This role will report to the Site Head.

HOW YOU’LL FLY

  • Develop, drive and support implementation of the site vision for operational excellence
  • Advance the design and implementation of a cross-functional management system, focused on identifying KPIs, visual controls for tracking their performance on a daily basis, and rapidly taking action based upon that performance.
  • Provide subject matter expertise in structured problem solving & root cause analysis, leading complex investigations and teaching/coaching others in problem solving methodology.
  • Build capabilities and lead execution of OE application support, including 5S, Leader Standard Work, Visual Controls, Risk Management, Change Management, Value Stream Mapping, and Strategy Deployment
  • Develop, drive and support implementation of the site vision for operational excellence
  • Advance the design and implementation of a cross-functional management system, focused on identifying KPIs, visual controls for tracking their performance on a daily basis, and rapidly taking action based upon that performance.
  • Provide subject matter expertise in structured problem solving & root cause analysis, leading complex investigations and teaching/coaching others in problem solving methodology.
  • Build capabilities and lead execution of OE application support, including 5S, Leader Standard Work, Visual Controls, Risk Management, Change Management, Value Stream Mapping, Strategy Deployment, and Continuous Improvement Processes.
  • Facilitate team meetings (site tier, operational readiness, project specific, etc.) using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
  • Develop and maintain integrated site project plans to identify/communicate interdependencies as well as critical path activities for start-up and tech transfer
  • As needed by project scope, provide direction and oversight for project manager/scheduler to maintain the integrated site schedule.
  • Owner of system for tracking site project deliverable schedule adherence, tracking root causes of schedule delays and mitigation actions.
  • Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects, as well as ensure team members are aware of integrated project timelines. 
  • Draft and issue routine sitewide and above site communication with updates on status of start-up and tech transfers.
  • Manage a project portfolio that aligns with the strategic objectives of the site.  (Multiple Tech Transfers, Commercial and Clinical, Capital projects, OE Improvements)
  • As a member of the Site Leadership Team, provide input, strategic direction and facilitation of periodic site strategy forums.
  • Lead scenario analyses for new initiatives and changes that impact the integrated start-up and tech transfer schedule.
  • Develop and maintain a site risk register to ensure risks are prioritized, communicated and mitigated effectively.
  • Facilitate and/or own risk assessments required for facility start-up and tech transfer."

WHAT YOU’LL BRING

  • BS in a scientific discipline with 8+ years of industry experience
  • Experience working in commercial and clinical GMP manufacturing
  • Lean Six Sigma certification or equivalent is strongly preferred, with a track record of implementing systems, problem solving and continuous improvement.
  • Experience with a new facility startup and/or process technology transfers 
  • Strong cross-functional knowledge of systems and operational requirements across Manufacturing, Supply Chain, Quality Control, Quality Assurance, Facilities/Maintenance, Engineering, MSAT, EH&S and IT
  • Expert knowledge and proficiency of MS Project, MS Visio, and the Microsoft Office Suite
  • Must be willing to have a flexible schedule to support 24x7 manufacturing activities. The role will be based in Durham, NC. Travel to Cambridge, MA, is expected to be <25%.

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.