Process Engineer II

This role is part of the Manufacturing Science and Technology (MSAT) Operations team at bluebird bio. The MSAT Process Engineer will be responsible for supporting viral vector and drug product manufacturing at partner CMOs. They will collaborate with Manufacturing and Quality counterparts to ensure a robust supply and support CMO performance. The role also involves reviewing process data, resolving deviations and investigations, and driving proactive measures to improve process performance. The ideal candidate will have technical expertise in cell culture, purification technologies, and/or fill/finish operations for biologics, viral vectors, and/or autologous cell therapy manufacturing.

• Serves as an accountable technical leader for upstream, downstream, and fill/finish manufacturing unit operations for plasmid, viral vectors, and/or autologous cell therapy manufacturing at partner CMOs.
• Collaborates with Manufacturing and Quality counterparts within bluebird to ensure robust supply and support CMO performance.
• Ensures timely review of process data and supports the resolution of deviations, investigations, change controls, and updates to regulatory documents.
• Use of standardized root cause analysis tools and statistical approaches to support investigations utilizing historical and process characterization data. Authors investigational and technical reports.
• Collaborates with MSAT counterparts at CMOs to deliver technical solutions to resolve investigations and drives proactive measures to improve process performance and robustness.
• Acts as person-in-plant (PIP) as needed for on-site oversight and support.
• Technical expertise in cell culture, purification technologies, and/or fill/finish operations for biologics, viral vectors and/or autologous cell therapy manufacturing.
• Track record of creative approaches to problem solving and improving efficiency of MSAT workflows.
• Prior experience supporting investigations, change controls, process monitoring, process validation, and routine commercial support in a GMP setting.
• Preferred experience in working with CMOs.
• Strong communication skills: clear, concise communication and resolution of complex technical issues across broad audiences and functional teams.
• Excellent organizational skills, with the ability to multi-task in an extremely fast-paced environment with changing priorities.

• S., M.S. or Ph.D. in a scientific or engineering discipline and 4 - 6+ years of experience for those who have B.S. or M.S. or 1+ years for those who have a Ph.D.
• Technical expertise in cell culture, purification technologies, and/or fill/finish operations for biologics, viral vectors and/or autologous cell therapy manufacturing.
• Track record of creative approaches to problem solving and improving efficiency of MSAT workflows.
• Prior experience supporting investigations, change controls, process monitoring, process validation, and routine commercial support in a GMP setting.
• Preferred experience in working with CMOs.
• Strong communication skills: clear, concise communication and resolution of complex technical issues across broad audiences and functional teams.
• Excellent organizational skills, with the ability to multi-task in an extremely fast-paced environment with changing priorities.

• Total compensation and rewards package that ranks among the best in the industry
• Base pay determined within a range, providing opportunity for progression
• Anticipated annualized salary range of $78,400.00 - $126,450.00
• Eligibility for stock, incentive bonuses, and benefit programs
• Flexible time off program
• 28 paid holidays, including 2 company shutdowns
• Commitment to fostering diversity and inclusion
• Equal opportunity employer, creating a welcoming and diverse environment