Process Engineer - Manufacturing Sciences & Technology
Core
Execute downstream technology transfer of biologic processes from development to GMP manufacturing, ensuring facility fit, equipment alignment, and process scalability.
Role type
Senior Process Engineer (Downstream Technology Transfer)
Builds
Scalable GMP manufacturing operations for monoclonal antibodies, fusion proteins, enzymes, and mRNA
Domain
Biologics manufacturing / Contract Development and Manufacturing Organization (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream biologics manufacturing (filtration, chromatography, TFF, viral filtration), cGMP compliance, process modeling, equipment qualification, technical documentation authoring, root cause analysis, cross-functional project management
Preferred skills
mRNA product development, mammalian cell culture, upstream processes, statistical data analysis, mentoring junior staff
Technologies
Single-use systems, chromatography, TFF, viral filtration
Responsibilities
Lead facility fit assessments and equipment alignment for technology transfer; Execute technical work plans and perform engineering calculations; Draft and review critical manufacturing documentation (batch records, transfer reports); Support GMP manufacturing through technical oversight and deviation/CAPA management; Identify process and equipment improvement opportunities; Partner cross-functionally with Process Development, Manufacturing, and Quality teams; Train and mentor junior staff on manufacturing principles
Seniority
Senior, hands-on IC with mentorship responsibilities
