Senior Manager, Regulatory CMC
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Senior Manager, Regulatory Science - CMC
We seek an experienced Regulatory CMC professional with specific expertise in biologics who will be responsible for planning, writing, and coordinating Regulatory CMC submissions (IND, IMPD, BLA/MAA) in collaboration with the Associate Director responsible for the Regulatory CMC development of bluebird bio’s late-stage LentiGlobin program. The Reg-CMC 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 product LentiGlobin in partnership with Pharmaceutical Sciences, Quality and Regulatory team members.
- Plan, prepare and oversee filing of high-quality CMCrelated‑ 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
- Outstanding communication skills
- Excellent scientific writing and editing skills
- Detail oriented; science-based reasoning skills
- Ability to execute and follow-through projects to completion
- 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 and solution oriented
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
Travel Required (Y/N, if yes, enter % of time): No
Manager of People (Y/N): No in short term, likely Yes in 3-5 years horizon
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.
Lyft is your friend with a car, whenever you need one