Uncubed
           

Sr. Manager, Project Management Lead for Commercial Gene Therapy Products

Bluebird Bio, Cambridge, Massachusetts, 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 an outstanding CMC Project Manager to drive late stage development / commercial-stage programs.  We seek candidates with proven ability to successfully provide PM leadership to support late stage to commercial launch and guide lifecycle management activities of complex products, with the ultimate goal of delivering therapies that transform the lives of patients. 

About the role:

  • Partner with CMC Scientific Lead to co-lead CMC teams for multiple complex late stage development and/or commercial projects to achieve product development, manufacturing and product lifecycle goals.
  • Develop and maintain integrated CMC project plans to identify/communicate interdependencies as well as critical path activities across multiple programs.
  • Work collaboratively with CMC functions (Process & Analytical Development, MS&T, LVV & DP Manufacturing, Cell Procurement/Vendor Mgmt, Supply Chain, Quality Control, Quality Assurance, and Regulatory) to ensure strong, clear communication to identify and address challenging issues in product development and manufacturing.
  • Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various CMC projects, as well as ensure CMC teams are aware of current integrated program timelines.
  • Facilitate CMC team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of CMC objectives.
  • Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement.

About you:

Education/Experience requirements:

  • Bachelor’s or Master’s degree in the life sciences.
  • 5+ years of relevant biopharmaceutical industry experience. Previous late phase (Phase 2/3 to Post Launch, lifecycle management) experience in analytical development, process development, and manufacturing of biologics/cell & gene therapy preferred.
  • 3+ years of Project Management at a fast-paced, innovative biotech/pharma company. Commercial project management experience preferred.
  • Expertise using MS Project/SmartSheet and SharePoint preferred.
  • Organizational Change Management experience in a fast-paced, innovative drug development environment preferred.

Soft Skills:

  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Proven ability to distill complex plans across multiple programs into an intuitive, simple and clear communication to facilitate prioritization and resourcing.
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Independently motivated, detail oriented and great problem-solving ability.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Excellent communication skills and ability to influence across multiple functions.

Cultural Fit:

  • A passion for addressing the critical unmet medical needs of patients
  • 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.