Help continue to build the bbb pipeline with new and exciting therapies
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 Operations & Strategic Planning Manager to drive early-phase (Research to Development) programs across CMC.
Reporting to the Associate Director of CMC Operations & Strategic Planning, the successful candidate will possess the proven ability to effectively integrate and clearly communicate interdependent CMC activities, as well as manage, mitigate, and appropriately escalate project risks across CMC functions. You will develop and manage optimized project plans with the goal of delivering therapies that transform the lives of patients.
About the role:
- Partner with CMC Scientific Lead to establish and co-lead CMC teams for multiple complex development projects to achieve product development and manufacturing goals
- Develop and maintain integrated CMC project plans to identify/communicate interdependencies as well as critical path and risk mitigation activities across multiple development programs
- 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
- Work collaboratively with Process and Analytical Development, Manufacturing, Global Supply Chain, MSAT, Quality Control, Quality Assurance, and Regulatory colleagues to ensure strong, clear communication and 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
- Bachelor's degree, Master’s degree or PhD in the life sciences is required
- Minimum of 5+ years of relevant biopharmaceutical industry experience is required
- Minimum of 3+ years of Project Management experience at a fast-paced company is necessary
- 2+ years as a Lean Six Sigma Black Belt with Organizational Change Management (OCM) experience in a fast-paced, innovative drug development environment desired
- Track record of successfully driving, managing and implementing Lean Six Sigma projects such that they integrate effectively with the overall objectives of the functions and/or corporation they support
- Previous experience in analytical development, process development, and manufacture of biologics/gene therapy preferred
- Experience in early-phase (Research to Development) project management experience preferred
- Expertise using MS Project and SharePoint is strongly desired
- Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
- Outstanding communication, analytical, and organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities
- 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, clear communication tool to facilitate prioritization and resourcing
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment and demonstrate problem-solving leadership
- Ability to navigate effectively in a collaborative team environment where results are achieved through influence across multiple functions and the incorporation of multiple points of view
- Effective in managing competing priorities, independently motivated, detail oriented, and proactive
- Ability to adeptly and successfully manage/implement change
- 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
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.