Director, Regulatory Science - CMC at Bluebird Bio Inc. in Cambridge, Massachusetts

Posted in Other 15 days ago.





Job Description:

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


The Regulatory Science flock is all about partnering with colleagues and global regulatory authorities to pioneer access to innovative, safe and effective gene therapies. Driven by our commitment to patients with severe genetic diseases, bluebird bio is looking for an experienced Regulatory CMC professional who will be responsible for the strategic development and submission of regulatory dossiers for gene therapy projects for severe genetic diseases (SGD). Join bluebird bio's enthusiastic and collaborative team and contribute to the transformation of medical practice.



HOW YOU'LL FLY


As a Regulatory Science bird reporting to our Sr. Director Regulatory Science CMC, you'll help to bring more patients their bluebird days by:



  • Providing regulatory CMC strategic leadership to support development of multiple innovative gene therapy products for the treatment of severe genetic diseases

  • Managing and implement planning, preparation and submission of high-quality CMC related applications in the US, EU and other regions

  • Ensuring that CMC-related applications, including INDs/CTAs, MAAs and BLAs are complete, well written, and meet all relevant requirements

  • Managing negotiations with regulatory agencies to resolve CMC issues and proactive interactions with regulators globally; prepare and submit responses to CMC questions; participate as needed in interactions with regulatory agencies during GMP and pre-approval inspections

  • Driving adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals

  • Assessing proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation

  • Partnering closely with Technical Development & Operations, Quality, Nonclinical, Clinical and Regulatory Project Leads to ensure achievement of submission deadlines and obtain timely approvals of bluebird bio CMC related applications

  • Participating in regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to bluebird bio in-house CMC teams and Project/Product teams

  • Participating as the Regulatory CMC lead in cross-functional initiatives to develop efficient and compliant practices to support the development and commercialization of gene therapy products for severe genetic diseases

  • Engaging in and assist with building an industry-leading Regulatory CMC team by supporting the hiring and development of Regulatory-CMC colleagues





WHAT YOU'LL BRING


You're the bird we're looking for if you possess:



  • Master's degree in biochemistry, chemistry, biology or related biopharmaceutical fields; PhD degree desirable

  • 10 years+ of relevant biopharmaceutical industry experience, and ideally including therapeutic product development

  • 7 years+ of experience in CMC-focused Regulatory Affairs preferably for biologics, and ideally with experience in MAA or BLA filings for cell or gene therapy, late stage clinical development, and/or post-approval regulatory dossier life-cycle management.

  • Excellent written and oral communication

  • Strong knowledge of current Good Manufacturing Practices (GMP), experience with on-site health authority inspections desirable

  • Familiarity with CMC operations, including Quality and Manufacturing technical strategy, as well as analytical and process development.

  • Strong leadership qualities including strategic thinking, innovation, mentoring, scaling, collaboration, etc.

  • Superb organizational and communication skills, both written and oral skills, and "do-what-it-takes" attitude

  • Independently motivated, detail-oriented and good problem-solving ability

  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment

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.