Process Engineer

Process EngineerBrainChild 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.Responsibilities:Support clinical manufacturing by leading investigations and troubleshooting activities as neededProvide on the floor GMP manufacturing support as neededSupport process development teams as the voice of manufacturing during clinical product developmentDrive technology transfer of manufacturing processes from development to external CMOs as a key member of cross-functional teamsSummarize data sets to management in order to ensure process changes/drift is understoodDrive and Support the effort to create established batch records, for both development and GMP ManufacturingDevelop and use systems for clinical manufacturing data collection and trendingSupport 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.Qualifications:4-5+ years in life sciences supporting process development or manufacturing process improvement and support activities preferably in cell therapyProficiency with life science data analysis and visualization tools and experience communicating technical messages to teamsAbility to travel approximately 15% of the time to support tech transfer activities and ongoing manufacturing$105,000 - $115,000 a year