Staff Engineer, Process Development and Manufacturing

Role: Staff Engineer in Protein Process Development supporting downstream purification, process transfer, validation, and GMP manufacturing for vaccine candidates. Objectives: ensure successful technology transfer to manufacturing, optimize processes, and support lifecycle management from development through commercialization. Responsibilities: lead downstream purification tech transfer and scale-up activities, provide technical support for GMP campaigns, serve as a subject matter expert in chromatography, filtration, and UF/DF; design and analyze small to pilot-scale studies; support process monitoring, troubleshooting, and continuous improvement; collaborate with CMOs, author technical documentation, and mentor junior staff. Requirements: PhD in Bio/Chemical Engineering, Microbiology, Chemistry, or Biochemistry with 8+ years, or relevant master’s/bachelor’s with more experience; extensive experience in downstream process development, characterization, and GMP manufacturing; expertise in chromatography, filtration, and process validation; strong statistical and data analysis skills; experience working with external manufacturing partners and regulatory support; hands-on pilot-scale lab experience; knowledge of cGMP. Preferred: vaccine or conjugate process experience, regulatory support, and experience with process validation techniques. HighValue: vaccine biologics, downstream purification, process transfer, validation, lifecycle management, GMP, clinical or commercial stage, onsite in San Carlos, CA, with a 4-day onsite workweek.