ProcessDevelopmentEngineer

## Description 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. ## Qualifications MS, or BS in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Chemistry, Biochemistry, Chemical Biology, or a similar field. For candidates with a BS, we’d like to see significant experience in process development and GMP environments (2-5 years). Experience in CMC (Chemistry, Manufacturing, and Controls), pharmaceutical/biopharmaceutical manufacturing, or related process development and automation is strongly preferred. Hands-on experience with operation of process equipment, solid mechanical aptitude, record keeping in a QMS, aseptic processing/clean rooms, and automation. ## Skills and Qualities Process operation and development – Demonstrated ability to execute process development activities, evaluate process performance, and provide recommendations through data-driven analysis and practical problem solving. Prior experience with GMP manufacturing process and managing relatio