Senior Manager, Regulatory CMC
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
We seek an experienced Regulatory CMC professional with specific expertise in biologics who will be responsible for planning, writing, and coordinating Regulatory CMC submissions (investigative and commercial filings) in collaboration with the Sr. Director responsible for the Regulatory CMC development of bluebird bio’s oncology program. The Reg CMC Sr. Manager will also be responsible for representing the department on multidisciplinary product development teams.
About the role:
- Contribute to the global CMC regulatory strategies for the development of bluebird gene therapy oncology products in partnership with Pharmaceutical Sciences, Quality and Regulatory team members.
- Plan, prepare and oversee filing of high-quality CMC-related submissions; this will require cross-functional interactions, excellent project management and writing skills, as well as a good understanding of the underlying science.
- Participate in interactions with regulatory agencies to resolve CMC issues; prepare and submit responses to CMC questions.
- Participate as needed in interactions with regulatory agencies during GMP inspections and pre-approval inspections in support of Quality and CMC teams
- Assess proposed manufacturing process changes and provide support to Associate Director to provide strategic regulatory guidance as to how to best implement changes globally.
- BA/BS degree in life sciences in biochemistry, chemistry, biology, chemical engineering or related field, advanced degree preferred
- 5+ years of relevant biopharmaceutical industry experience with 3+ years of experience in Regulatory Affairs. Previous experience in process development, manufacturing, and quality of biologics/gene or cell therapy preferred
- Understanding of relevant drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
- Effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks and work under time pressure
- Ability to work both independently or collaboratively in a team structure and thrive in a fast-paced environment
- 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 with changing priorities
- 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.