Staff Engineer, Process Development and Manufacturing
Core
Staff Engineer leading downstream purification technology transfer, scale-up, GMP manufacturing support, and process lifecycle management for protein vaccines.
Role type
Staff Engineer, Process Development and Manufacturing (Downstream)
Builds
High-fidelity bacterial vaccines (pneumococcal, Group A Strep, Shigella)
Domain
Biopharmaceuticals / Vaccine Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
downstream purification, chromatography, filtration, UF/DF, scale-up, process characterization, GMP compliance, statistical analysis, predictive modeling, root cause analysis, CMO partnership, technical writing
Preferred skills
vaccine or conjugate manufacturing, regulatory filings, Transitional Analysis for Column Integrity Testing
Technologies
chromatography, filtration, UF/DF, predictive modeling tools
Responsibilities
Lead downstream purification technology transfer and scale-up from development to GMP; Provide technical support for GMP campaigns, process validation (PPQ), and continued process verification (CPV); Design and analyze pilot-scale studies for process characterization and comparability; Partner with CMOs for manufacturing readiness and execution; Mentor junior scientists and engineers; Author regulatory support documents and lead inspection readiness activities.
Seniority
Staff, hands-on IC with technical leadership