Senior Process Engineer, Manufacturing Sciences and Technology
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 and cell therapy approach. The focus of this position is to provide drug product process support for technology transfer and GMP manufacturing operations for our gene therapy products.
About the role:
- Leads cross-functional teams in tech transfers and process validations
- May work as point of contact for a given program both internally and with external contract manufacturing organization.
- Serve as technical expert for the drug product manufacturing process on internal and external teams.
- Provide technical support of GMP manufacturing runs and perform hand-on experiments in the laboratory as needed.
- Provide person-in-plant as needed for on-site oversight and support of process engineering or training runs.
- Must have proficient computer skills and be experienced using MS office software (Word, Excel and PowerPoint) and MS project.
- Work closely with Manufacturing, Quality Assurance, and external parties to successfully resolve deviations, investigations, change controls, etc.
- Manage timelines and deliverables for technology transfer to CMOs and conduct onsite or offsite training of contract manufacturing personnel.
- Perform process analysis and trend process performance; summarize findings in reports and presentations.
- Up to 10% travel with some potential support required on weekends.
- BS/MS with 7+ years of experience in manufacturing sciences, process development, manufacturing, or related areas.
- Tech transfer and process validation experience required.
- CMO experience is a plus.
- Familiar with FDA and EU regulations and GMP standards.
- Prior cGMP cell or gene therapy manufacturing experience is highly desired.
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
- Strong verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- 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.