Staff Engineer, Process Development and Manufacturing

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Our mission includes eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella. Our work is guided by four enduring core values:

• Rethink Convention: We bring creative and intellectual diversity to innovate and re-innovate vaccine delivery.
• Aim High: We courageously make the most complex biologics ever attempted to protect humankind.
• Lead with Heart: We collaborate with kindness and inclusivity, advancing business objectives through vigorous debate.
• Model Excellence: We demonstrate integrity, accountability, equality, and clarity in communications and decision-making.

About the Role

Vaxcyte is seeking a highly motivated Staff Engineer to join the Protein Process Development and Manufacturing group. This role supports downstream purification, process development, technology transfer, process validation, GMP manufacturing support, and process lifecycle management. Initially, the focus will be on technology transfer, manufacturing support, process validation, and commercialization activities for protein manufacturing processes.

The successful candidate will partner closely with Contract Manufacturing Organizations (CMOs) and internal stakeholders to ensure successful transfer, scale-up, validation, and commercial execution of downstream purification processes. This individual will serve as a recognized technical authority in downstream purification, influencing program-level decisions across process development, technology transfer, validation, and commercial manufacturing.

As commercial manufacturing processes mature, this position will evolve toward a broader Process Development role, including process optimization, next-generation process development, scale-down model development, process characterization, pilot-scale studies, and lifecycle process improvement. This offers a unique opportunity to work across the full product lifecycle while shaping the future downstream purification strategy.

Responsibilities

• Lead downstream purification technology transfer and scale-up activities from Process Development to GMP manufacturing facilities for clinical and commercial programs.
• Provide technical support for GMP manufacturing campaigns, process validation (PPQ), continued process verification (CPV), and lifecycle process management.
• Serve as a subject matter expert and technical leader in downstream purification operations, including chromatography, filtration, UF/DF, scale-up, and process characterization.
• Design, execute, and analyze small-scale and pilot-scale studies supporting process characterization, comparability assessments, validation strategies, troubleshooting investigations, and process lifecycle management.
• Support process monitoring, statistical data analysis, predictive modeling, trend analysis, troubleshooting, and root cause investigations to improve process robustness and performance.
• Partner with CMOs and cross-functional teams to support successful process transfer, manufacturing readiness, compliance, and operational execution.
• Drive continuous improvement and risk mitigation initiatives, applying scientific and engineering principles to solve complex process and manufacturing challenges.
• Apply advanced statistical analysis and predictive modeling tools to evaluate process performance, identify trends, and support data-driven decision-making.
• Author and review technical documentation, regulatory support documents, deviations/investigations, and technical assessments.
• Support inspection readiness activities and responses to regulatory observations.
• Mentor junior scientists and engineers, providing technical leadership to shape team capabilities and establish best practices.

Requirements

• PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 8+ years of relevant Pharma/Biotech industry experience, or Master’s degree with 13+ years, or Bachelor’s degree with 16+ years.
• 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 processes.
• Experience supporting GMP manufacturing, late-stage clinical or commercial manufacturing programs, process validation, and lifecycle process management (PPQ and CPV programs).
• Demonstrated experience applying statistical analysis, multivariate data analysis, and predictive modeling for process characterization, validation, and manufacturing monitoring.
• Experience leading complex technical deviations, troubleshooting, and root cause analysis.
• Experience working with CMOs and external manufacturing partners.
• Hands-on experience with laboratory-scale and pilot-scale purification operations.
• Strong knowledge of cGMP regulations and manufacturing quality/compliance systems.
• Excellent communication, technical writing, cross-functional leadership, project management, and presentation skills.
• Demonstrated ability to influence matrix teams without direct authority.
• Prior experience with vaccine or conjugate manufacturing processes preferred.
• Experience supporting regulatory filings and health authority inspections preferred.
• Experience implementing or supporting Transitional Analysis for Column Integrity Testing preferred.

Schedule

Onsite - 4 days per week in San Carlos, CA.

Pay

Salary Range: $186,000 – $218,000 (SF Bay Area). The compensation package is competitive and includes comprehensive benefits and an equity component.