Senior Scientist/Senior Manager, Late Stage Process Development
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. The focus of this position is to provide leadership and support to the Cellular Process Development and Gene Editing group on late stage activities including drug product process characterization and validation readiness. Team activities include the development and qualification of scale down models, designing process characterization studies, implementing process improvements in late-stage development, interpreting results to establish a process control strategy, authoring process characterization reports, risk assessments, and BLA/MAA sections, and providing Subject Matter Expert (SME) support to CMC teams and manufacturing teams for bluebird bio’s Severe Genetic Disease (SGD) clinical programs. This person will collaborate across all functional areas to ensure project advancement in a timely manner, rapid and best in class execution, and communication of challenges/opportunities. The successful candidate will be a subject matter expert for Hematopoietic Stem Cell (HSC) processes going through late stage clinical trials in preparation for commercialization.
About the position:
- Responsible for defining and maintaining deliverables for cellular therapy late stage process development through process commercialization
- Responsible for defining and driving a scientific strategy for implementation, characterization and validation of HSC manufacturing processes using a risk-based approach
- Responsible for supporting CMC as a functional team representative and supporting manufacturing clinical deviations and change controls. Act as a technical liaison between the Cellular Process Development and other functions such as MSAT and manufacturing.
- Responsible for leading a team of scientists in the lab working on Hematopoietic Stem Cell (HSC) process characterization and support clinical investigations
- Author and review documentation to support the late stage activities of the group and establishing a suitable process control strategy
- Author and review appropriate sections of regulatory filings
- Provide technical input to the manufacturing operations team in support of clinical activities
- Promote and ensure efficient and timely readiness for PPQ campaign in close collaboration with cross-functional teams
- Manage experimental timelines to meet corporate goals
- Must be willing to have a flexible schedule based on experimental and company needs (including possible weekend work and travel, may require up to 20% travel)
- MS with 10+ years of relevant experience or Ph.D in cell biology, immunology, biological sciences, biomedical/chemical engineering or related field with at least 5+ years of relevant experience.
- Previous experience managing/mentoring scientists in a laboratory setting is required
- Technical understanding and experience in biopharmaceutical process manufacturing operations in an industrial cGMP environment
- Strong background in cell culture operations is a must and experience with large scale equipment such as selection equipment for stem cells is preferred
- Experience with quality by design (QbD) and Design of Experiments (DoE) approaches to process characterization using statistical software such as JMP for applications of statistical process control
- Preference will be given to candidates with late stage process development experience, tech transfer experience, and commercialization (PPQ, PAI, BLA, MAA) experience
- Prior experience with cellular therapy, gene therapy or gene editing process and/or analytical development is highly desirable
- Experience with lean Six Sigma philosophy, 5S, or DMAIC philosophy and how it relates to manufacturing is desirable
- Strong scientific and technical mastery, which includes demonstration of strong technical writing and presentations. Direct experience authoring Risks Assessments, Process Characterization and Process Characterization Summary/Justification reports is highly preferred.
- Independently motivated, detail oriented and good problem-solving ability
- Excellent communications skills, mentoring skills, and ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Excellent organizational skills with an ability to embrace change and multi-task in a fast-paced environment, meet tight deadlines, and prioritize multiple projects
- Experience supporting manufacturing in deviations and change controls as a SME is a plus
- Experience working with breakthrough/accelerated developments using a risk-based approach is a plus
- Good understanding of regulations and standards for the processing of cellular therapy products in different countries and platforms is a plus
- 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.