Process Development Engineer

5AM Ventures•Emeryville, CA

2d•$85,000 - $125,000

About The Position

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.

Requirements

MS, or BS in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Chemistry, Biochemistry, Chemical Biology, or a similar field.
For candidates with a BS, significant experience in process development and GMP environments (2-5 years).
Hands-on experience with operation of process equipment
Solid mechanical aptitude
Record keeping in a QMS
Aseptic processing/clean rooms
Automation
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.
Meticulous attention to detail and record keeping.
Strong mechanical aptitude and experience in the use of tools for operation, assembly, and maintenance of development laboratory equipment and infrastructure.

Nice To Haves

Experience in CMC (Chemistry, Manufacturing, and Controls), pharmaceutical/biopharmaceutical manufacturing, or related process development and automation is strongly preferred.
Prior experience with GMP manufacturing process and managing relations with equipment providers is a huge bonus.
Familiarity with operating in a GMP QMS environment (batch records, deviations, CAPA, change control) is strongly preferred.
Familiarity with CAD and mechanical design would be a plus, especially when it comes to sourcing parts or working with equipment design.

Responsibilities

Oversight and hands-on validation of our process that employs custom equipment
Identifying process improvements
Troubleshooting complex issues
Generating manufacturing method SOPs
Maintaining a controlled inventory of equipment parts and records within our GMP-like Quality Management System (QMS)
Hands-on process development in our lab
Process technology research
Reporting and record keeping
Tech transfer support and troubleshooting at CMO sites