Senior Process Engineer

BrainChild Bio is seeking to hire a Senior Process Engineer to add to our growing team. This role will provide critical support to technology transfer, process development and manufacturing activities of BrainChild programs including but not limited to helping driving technology transfers to external CMOs, delivering routine manufacturing and investigational support to manufacturing, equipment specification, and interacting with PD and R&D to drive changes necessary for late stage/commercial operations. The ideal candidate will exhibit an understanding of both cell therapy and viral vector processes.  They will have a problem-solving mindset and bring deep curiosity in understanding the process variables and interactions that drive specific attributes throughout the process and product.  They have a passion for learning and will build excitement in others about finding solutions and seeking truth. They will have experience with GMPs, manufacturing operations, equipment specifications and/or procurement, interacting with Quality, creating batch records and SOPs, owning change controls, deviations, providing on the floor support, and interpreting data. Minimally, they will have a basic understanding and experience with process lifecycle documents such as QTPP, establishing CQA’s, process risk assessments, and Process Control Strategies.  Experience with comparability strategies / submissions would be beneficial. They’ve been key members of cross-functional teams and helped drive successful tech transfers and/or process improvement efforts.

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

Qualifications:

• 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!