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.
Principal Project Manager – Regulatory CMC
ABOUT THE FLOCK
Driven by our responsibility to patients, bluebird bio’s Regulatory Science team partners with colleagues and global regulatory authorities to pioneer access to innovative, safe and effective gene and cell therapies for severe genetic diseases. Join bluebird bio’s enthusiastic and collaborative team and contribute to the transformation of medical practice. We are seeking an outstanding Regulatory Chemistry, Manufacturing & Controls (CMC) Project Manager to join the growing Regulatory Science - CMC team. In this role the Regulatory CMC Project Manager will manage internal activities for specified projects at all development stages, interfacing with relevant Regulatory Science and CMC functional groups. The incumbent will be expected to use key project management tools to plan and track project deliverables and facilitate communication of regulatory activities across sub-teams and to management. The Regulatory CMC Project Manager will manage detailed regulatory CMC submission timelines across multiple programs and workstreams and will interface with other project managers to integrate Regulatory CMC plans with overall plans and ensure planning, impact, coordination and communication.
HOW YOU’LL FLY
As a Regulatory bird reporting to VP, Regulatory, you'll help to bring more patients their bluebird days by:
- Working closely with leaders within the Regulatory CMC team to proactively plan, manage, and course-correct work to enable on-time regulatory submissions that meet quality expectations. Effective cross-functional collaboration with technical subject matter experts will be a key part of the role and require finesse, leadership and patience. Management of project plans and timelines for the completion of all activities required to develop, prepare and submit the CMC variations, changes, and amendments for all products
Identifying both regulatory and project risks, with potential solutions to cross-functional project team and leadership as needed
• Leading and managing the planning and creation of a detailed project plan for projects with input from identified stakeholders and through collaboration with functional representatives
• Working with Regulatory-CMC product leads and CMC and Quality functions to understand the individual deliverables, interdependencies between deliverables and resource requirements/constraints to create and maintain individual submission timelines and overall franchise portfolio views of project plans and timelines
• Contributing to development of best practices and standardized processes for dossier lifecycle management with Reg-CMC product leads and cross-functional stakeholders
• Partnering with Regulatory-CMC leads to run project meetings, communicate progress, and prioritize activities
• Facilitating team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans and major regulatory submissions
• Preparing meeting agendas and clear meeting communication documents, such as minutes and decision registers, action items and effective issue and risk mitigation plans. Organize and maintain this team information in a central location using preferred technologies such as SharePoint, OneNote, and OneDrive.
• Leads initiatives to develop, improve and implement regulatory project management operational standards related to Regulatory-CMC business processes.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
Bachelor’s degree required
• A minimum of 7 years working for a company focused on the development of biotech and / or pharmaceutical products
• A minimum of 3 years of Regulatory/CMC project management experience in the biotechnology/pharmaceutical industry
• Knowledgeable in entire life cycle of drug development and understanding of ICH guidelines and CTD structure
• Expertise in management methodologies and tools; identifying and driving strategic initiatives such as process improvements and/or functional projects.
• Experience developing project plans, content plans and strong time and Microsoft Project skills
• Demonstrated ability to collaborate and communicate across organizational levels and disciplines, with excellent communication and inter-personal skills
• Proven ability to communicate clearly and present key information objectively
• Experienced working with teams in a matrix organization; can lead and motivate team members without direct line management responsibility. Develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others both inside and outside the department.
• Ability to understand and analyze complex issues and develop creative and achievable solutions
• Ability to identify, advocate and implement change positively for the organization. Demonstrates flexibility and the ability to accommodate change.
• Excels when working in a fast-paced environment and driven to succeed; motivated to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion
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.