BrainChild Bio

Engineer

• 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

Senior Process Engineer