Engineer III, Process Development
Core
Design and implement next-generation automated manufacturing systems for mRNA-based medicines, focusing on process understanding, control strategies, and technology transfer.
Role type
Senior IC process development engineer (biopharma manufacturing)
Builds
Automated, integrated manufacturing platforms for Drug Substance production
Domain
Biopharmaceuticals / mRNA therapeutics / Chemical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Chromatography, ultrafiltration, normal flow filtration, nucleic acid drug development, process design, equipment specification, GxP/GMP compliance, experimental design and analysis
Preferred skills
Technology transfer, bioprocess skid design, automation, process analytical technologies (PAT), personalized medicine manufacturing, FDA/EMA/ICH regulations
Technologies
GxP, GMP, FDA, EMA, ICH
Responsibilities
Translate RNA manufacturing processes into functional and technical requirements for automated systems; Develop process flow diagrams (PFDs), P&IDs, and requirement specifications; Support design, scale-up, and implementation of modular process skids; Partner with vendors to design novel manufacturing platforms for closed and continuous operations; Contribute to Clean-In-Place (CIP) system design and optimization; Support global site startup activities via tech transfer and process investigations
Seniority
Senior, hands-on IC