Process Engineer

Process Engineer BrainChild Bio is seeking to hire a 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. This will include but not be limited to helping execute successful technology transfers to external CMOs, delivering real time support to manufacturing, including investigational support, in person and remote support to manufacturing, interaction with QA, PD and R&D, and acting as the stakeholder voice of manufacturing operations. The ideal candidate will exhibit a problem-solving mindset, deep curiosity, and an understanding of cell therapy and/or vector manufacturing processes. We are looking for a candidate that has a passion for learning and will build excitement in others about finding solutions and seeking truth. They will bring experience with GMPs, manufacturing operations, batch records and SOPs, change controls and deviations. The candidate will preferably bring experience reviewing and interpreting data and be able to summarize key takeaways. They will have a basic understanding and experience with the CMC drug development lifecycle, process risk assessments and Process Control Strategies. Ideally, they've been key members of cross-functional teams and helped drive successful tech transfers and/or process improvement efforts.

Support clinical manufacturing by leading investigations, providing input to change controls, and troubleshooting activities as neededSupport process risk assessments as needed to drive further characterization studies and/or Process Control Strategy documents.