Senior Manager, Regulatory CMC 10/11/2019
Bluebird Bio Inc.
JOB DESCRIPTIONAPPLY 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.
bluebird bio is committed to fostering an environment where everyone can be their whole selves and know they are valued. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, age, gender (including pregnancy, childbirth, or related medical conditions), sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or other applicable legally protected characteristics.