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Company | bluebird bio |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-09-13 |
Posted at | 8 months ago |
About The Nest
- Be Compassionate
- Keep it real
- Celebrate (sm)all wins
- Stay humble and curious
- Persist for Purpose
- 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.
- Acts as person-in-plant (PIP) as needed for on-site oversight and support.
- 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 Manufacturing and Quality counterparts within bluebird to ensure robust supply and support CMO performance.
- Collaborates with MSAT counterparts at CMOs to deliver technical solutions to resolve investigations and drives proactive measures to improve process performance and robustness.
- 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.
- Excellent organizational skills, with the ability to multi-task in an extremely fast-paced environment with changing priorities.
- Prior experience supporting investigations, change controls, process monitoring, process validation, and routine commercial support in a GMP setting.
- Strong communication skills: clear, concise communication and resolution of complex technical issues across broad audiences and functional teams.
- Track record of creative approaches to problem solving and improving efficiency of MSAT workflows.
- Technical expertise in cell culture, purification technologies, and/or fill/finish operations for biologics, viral vectors and/or autologous cell therapy manufacturing.
- Preferred experience in working with CMOs.
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