Staff Engineer, Drug Substance, MSAT

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our work is guided by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.

Responsibilities

• Support conjugation manufacturing operations from commercial readiness through PPQ and ongoing commercial production at CMO sites
• Provide technical and operational support to ensure robust and efficient manufacturing processes
• Work cross-functionally with program management, process development, quality, regulatory, and CMO management
• Execute statistical thinking and data analysis using DOE, process capability, and CPV trending
• Oversee CMO service providers to ensure delivery of commercial readiness and process validation
• Lead DS manufacturing process investigations and CAPAs
• Drive continuous improvement and change management through technological innovation
• Author and review technical reports, manufacturing documents, and regulatory submissions
• Support CMOs during health authority inspections

Requirements

• PhD in Bio/Chemical Engineering, Microbiology, Chemistry, or Biochemistry with 9+ years of Pharma/Biotech experience, or Master's degree with 12+ years of experience
• Strong experience in Drug Substance Manufacturing under GMP regulations
• Deep knowledge of protein-polysaccharide conjugation principles (activation/coupling chemistries, reaction kinetics, impurity formation)
• Proficiency in statistical thinking and data analysis (DOE, process capability, control charts)
• Hands-on experience with biochemical reaction, product recovery, and purification processes
• Knowledge of unit operations such as homogenization, centrifugation, depth filtration, chromatography, and UF/DF TFF
• Strong troubleshooting skills and experience with FMEA and CAPAs
• Proven technical leadership and project management skills
• Fluency in English