Summary:

Vaxcyte is seeking a highly motivated Staff Engineer to join the Protein Process Development and Manufacturing group supporting downstream purification, process development, technology transfer, process validation, GMP manufacturing support, and process lifecycle management.  

This role is initially focused 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.   

The individual will serve as a recognized technical authority in downstream purification whose scientific expertise and engineering judgment influence program-level decisions across process development, technology transfer, validation, and commercial manufacturing. The successful candidate will provide leadership in solving complex technical challenges, developing innovative solutions, and guiding cross-functional teams through critical manufacturing and process development decisions. 

As commercial manufacturing processes mature and transition into routine operation, this position is expected to evolve toward a broader Process Development role with increasing involvement in process optimization, next-generation process development, scale-down model development, process characterization, pilot-scale studies, and lifecycle process improvement. This provides a unique opportunity to work across the full product lifecycle, from development through commercial manufacturing and continuous process improvement, while helping shape the future downstream purification strategy for the Protein organization. 

Essential Functions:

• 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 and apply scientific and engineering principles to solve complex process and manufacturing challenges and develop innovative technical solutions. 

• Apply advanced statistical analysis and predictive modeling tools to evaluate process performance, identify emerging trends, predict manufacturing outcomes, and support data-driven decision making across technology transfer and commercial manufacturing activities. 

• 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 and provide technical leadership across programs and project teams that shapes the team's capability development and establishes best practices across the programs. 

 Requirements:

• PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 8+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 13+ years of relevant Pharma/Biotech industry experience or Bachelor’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 16+ years of relevant Pharma/Biotech industry experience 
• 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 techniques to support data-driven decision-making tools for process characterization, technology transfer, process validation, continued process verification (CPV), and manufacturing process monitoring. 
• Experience leading complex technical deviations / investigations, 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 implementation of Transitional Analysis for Column Integrity Testing preferred.  

Reports to: Associate Director, MSAT (Protein Process Development and Manufacturing (Downstream) 

Location: Onsite (San Carlos, CA)

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Onsite - 4 days per week onsite

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $186,000 – $218,000 (SF Bay Area).