Posted 2 days ago
Process Development Engineer
AI Summary
In this newly created role, as a Process Development Engineer I, you will work in close collaboration with our Process Development team, and our Senior Process Engineer in particular, to advance our manufacturing process technology for drug-releasing microspheres, as we begin scale-up to enable later phase GMP production.
About this role
In this newly created role, as a Process Development Engineer I, you will work in close collaboration with our Process Development team, and our Senior Process Engineer in particular, to advance our manufacturing process technology for drug-releasing microspheres, as we begin scale-up to enable later phase GMP production. Key aspects of your role include oversight and hands-on validation of our process that employs custom equipment, identifying process improvements, troubleshooting complex issues, generating manufacturing method SOPs, and maintaining a controlled inventory of equipment parts and records within our GMP-like Quality Management System (QMS).
This role involves hands-on process development in our lab, process technology research, and reporting and record keeping. We’re looking for an extremely organized, critical problem solver who brings experience that may include process chemistry, mechanical engineering, GMP manufacturing, process equipment maintenance, process automation, and knowledge of record keeping within a QMS.