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!
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