Staff Engineer, Drug Substance, MSAT
Core
Staff Engineer leading Drug Substance manufacturing operations for protein-polysaccharide conjugate vaccines at contract manufacturing organizations (CMOs), ensuring commercial readiness, process validation, and efficient GMP production.
Role type
Staff Engineer, Drug Substance Manufacturing (Bioconjugates)
Builds
Commercial-grade protein-polysaccharide conjugate Drug Substances for bacterial disease vaccines
Domain
Biopharmaceuticals / Vaccine Manufacturing / Bioconjugation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
protein-polysaccharide conjugation chemistry, statistical process control (DOE, CPV), GMP compliance, process troubleshooting, FMEA, technology transfer, unit operations (chromatography, TFF, centrifugation), CMO management, CAPA development
Preferred skills
vaccine manufacturing experience, drug substance equipment qualification, facility fit assessment, scale-down studies, cross-functional leadership
Technologies
DOE tools, control charts, chromatography systems, UF/DF TFF, microfluidization, depth filtration
Responsibilities
oversee CMO service providers for commercial manufacturing campaigns, execute statistical data analysis for process verification, lead manufacturing process investigations and CAPAs, drive continuous improvement in conjugation processes, support technology transfer and process validation, present technical findings to senior management and external conferences
Seniority
Senior, hands-on IC with technical leadership