SeniorFull TimeEN
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.
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