Senior Process Engineer - Manufacturing Sciences & Technology
Core
Senior Process Engineer supporting technology transfer and process readiness for downstream biologics manufacturing (mammalian cell lines, mRNA, protein therapeutics) from Process Development to GMP production.
Role type
Senior IC Process Engineer (Downstream Biologics)
Builds
GMP-compliant biologic drug substances for clinical and commercial supply
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Downstream biologics process expertise (depth filtration, chromatography, TFF, viral filtration), Technology transfer execution, GMP/cGMP compliance, Deviation/CAPA/Change control management, Batch documentation authoring, Equipment qualification & troubleshooting, Statistical data analysis, Cross-functional project leadership
Preferred skills
Subject matter expertise in large-scale mRNA and protein therapeutics manufacturing, Commercial-scale process optimization (via careerplan.io/jobs/0096869-senior-process-engineer-manufacturing-sciences-technology-at-catalent)
Technologies
Single-use systems, Chromatography systems, Filtration systems, GMP manufacturing equipment
Responsibilities
Oversee technology transfer between Process Development and Manufacturing; Evaluate and recommend equipment/process improvements; Author and review technical documents (protocols, SOPs, batch records); Lead risk assessments, gap analyses, and root-cause analysis; Mentor staff and provide technical oversight for GMP operations; Compile process data and deliver client presentations.
Seniority
Senior, hands-on IC with leadership responsibilities