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About the role
- Senior Process Engineer supporting technology transfer and manufacturing at BrainChild Bio. Collaborating with cross-functional teams to optimize processes in cell therapy.
Responsibilities
- Drive technology transfer of manufacturing processes from development to external CMOs as a key member of cross-functional teams, serving as the Process Owner and Equipment Owner
- Support process development teams as the voice of manufacturing during clinical product development
- Drive and Support the effort to create batch records and SOPs, for both process development and GMP Manufacturing
- Specify and/or purchase equipment and interact with Equipment vendors directly.
- Specify and/or investigate new raw materials and interact with new raw material vendors
- Support clinical manufacturing through and past tech transfer including on the floor support, leading investigations, supporting deviations and troubleshooting
- Execute or support process risk assessments as needed to drive further tech transfers, Comparability, characterization studies and/or Process Control Strategy documents.
- Build and develop process engineering toolset and best practices for data analysis and communication. Be able to summarize data sets to management
Requirements
- Minimum BS in Bioengineering, Chemical Engineering, Biology, or other related discipline
- 7+ years in life sciences supporting process development or manufacturing process improvement and support activities preferably in cell therapy
- Proficiency with investigations, creating protocols, reports, performing data analysis and experience communicating technical messages to teams
- Ability to travel up to 15% of the time to support tech transfer activities
- Ability to be flexible in job responsibilities – come wear a bunch of different hats!
- Must live in the Seattle area
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