Staff Engineer, Process Development and Manufacturing (Biotech)

Location: Onsite in San Carlos, California, United States; 4 days per week onsite.

Salary: $186,000–$218,000 annually in the San Francisco Bay Area.

Company

Vaxcyte develops vaccine products and protein manufacturing processes.

What you will do

• Lead downstream purification technology transfer and scale-up from process development to GMP manufacturing facilities.
• Provide technical support for GMP manufacturing campaigns, PPQ, CPV, and lifecycle process management.
• Act as a technical authority for chromatography, filtration, UF/DF, scale-up, and process characterization.
• Design, execute, and analyze laboratory- and pilot-scale studies for characterization, comparability, validation, troubleshooting, and lifecycle improvement.
• Apply statistical analysis, predictive modeling, trend analysis, and root cause investigations to improve process robustness.
• Partner with CMOs and cross-functional teams, author technical and regulatory documentation, support inspection readiness, and mentor junior scientists and engineers.

Requirements

• PhD with 8+ years, Master’s degree with 13+ years, or Bachelor’s degree with 16+ years of relevant pharmaceutical or biotechnology industry experience in bio/chemical engineering, microbiology, chemistry, or biochemistry.
• Extensive experience in downstream purification process development, process characterization, technology transfer, scale-up, and GMP manufacturing support.
• Strong expertise in chromatography, filtration, UF/DF, and downstream processing.
• Experience with late-stage clinical or commercial manufacturing, process validation, PPQ, CPV, lifecycle management, and laboratory- or pilot-scale purification.
• Experience with statistical analysis, multivariate data analysis, predictive modeling, technical investigations, troubleshooting, and root cause analysis.
• Knowledge of cGMP regulations, manufacturing quality systems, technical writing, cross-functional leadership, project management, and influencing matrix teams without direct authority.

Nice to have

• Experience with vaccine or conjugate manufacturing processes.
• Experience supporting regulatory filings and health authority inspections.
• Experience implementing or supporting Transitional Analysis for Column Integrity Testing.

Culture & Benefits

• Onsite work arrangement that may change based on business needs, job responsibilities, or company policy.
• Comprehensive benefits package.
• Equity component included in the compensation package.
• Work involves collaboration with CMOs, internal stakeholders, and cross-functional program teams.