Senior Process Engineer - Manufacturing Sciences & Technology, Upstream
Core
Senior Process Engineer supporting technology transfer between process development and GMP manufacturing for mammalian biologics.
Role type
Senior IC process engineer (upstream biologics)
Builds
GMP-compliant biologic drug substances at clinical to commercial scales
Domain
Biopharmaceuticals / Upstream Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
mammalian cell culture, in vitro transcription, facility fit assessment, process scaling, cGMP compliance, deviation/CAPA management, technical documentation authoring, statistical data analysis, equipment troubleshooting, single-use systems operation
Preferred skills
large-scale commercial biologics manufacturing expertise, mRNA product development experience
Technologies
single-use systems, GMP manufacturing equipment
Responsibilities
Oversee technology transfer between external clients and manufacturing; evaluate and recommend equipment/process improvements; author and review critical technical documents (protocols, SOPs, batch records); lead risk assessments, gap analysis, and root-cause analysis; mentor staff and lead cross-functional projects; support commercial program operations and qualification.
Seniority
Senior, hands-on IC with leadership responsibilities
