Staff Engineer, Downstream Process Development and Manufacturing

Staff Engineer, Process Development and Manufacturing
Clinical San Carlos , California Direct Hire Aug 20, 2026

Location: San Carlos, California
Work Arrangement: Onsite, a minimum of four days per week
Salary Range: $186,000-$218,000
Reports to: Associate Director, MSAT - Protein Process Development and Manufacturing, Downstream

Viltis is partnering with a clinical-stage vaccine innovation company to identify an accomplished Staff Engineer for its Protein Process Development and Manufacturing organization.

Our client is developing advanced vaccines designed to protect people from serious bacterial diseases. This is an opportunity to join a mission-driven organization working on technically complex biologics with the potential to deliver a meaningful global health impact.

The company values scientific creativity, ambitious thinking, inclusive collaboration, accountability, integrity, and excellence in communication and decision-making.

The Staff Engineer will provide technical leadership across downstream purification, process development, technology transfer, process validation, GMP manufacturing support, and process lifecycle management.

Initially, the position will focus on technology transfer, manufacturing support, process validation, and commercialization activities for protein manufacturing processes. The successful candidate will work closely with Contract Manufacturing Organizations (CMOs) and internal stakeholders to ensure the effective transfer, scale-up, validation, and commercial execution of downstream purification processes.

This individual will serve as a recognized technical authority in downstream purification. Their scientific expertise and engineering judgment will influence program-level decisions spanning process development, technology transfer, validation, and commercial manufacturing.

The Staff Engineer will lead the resolution of complex technical challenges, develop innovative and practical solutions, and guide cross-functional teams through critical manufacturing and process-development decisions.

As commercial manufacturing processes mature and transition into routine operations, the position will expand into a broader Process Development role. Responsibilities will increasingly encompass process optimization, next-generation process development, scale-down model development, process characterization, pilot-scale studies, and lifecycle process improvement.

This role offers a unique opportunity to contribute across the entire product lifecycle—from development and commercialization through routine manufacturing and continuous process improvement—while helping shape the organization’s future downstream purification strategy.

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 performance qualification (PPQ), continued process verification (CPV), and lifecycle process management.

Serve as a subject-matter expert and technical leader for downstream purification operations, including chromatography, filtration, ultrafiltration/diafiltration (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…