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 relations with equipment providers is a huge bonus, as we expect this role to involve several collaborations with equipment providers.
Meticulous attention to detail and record keeping. You take pride in generating clear, accurate, and traceable documentation.
Familiarity with operating in a GMP QMS environment (batch records, deviations, CAPA, change control) is strongly preferred.
Strong mechanical aptitude and experience in the use of tools for operation, assembly, and maintenance of development laboratory equipment and infrastructure.
Familiarity with CAD and mechanical design would be a plus, especially when it comes to sourcing parts or working with equipment design.
This role may require some domestic and international travel to CMO sites for on-the-ground tech transfer support and troubleshooting.
