Staff Engineer, Process Development and Manufacturing

About the Role

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, influencing program-level decisions spanning process development, technology transfer, validation, and commercial manufacturing. The 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.

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 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 internal cross-functional teams to support successful process transfer, manufacturing readiness, regulatory compliance, and operational execution.
• Drive continuous-improvement and risk-mitigation initiatives by applying scientific and engineering principles to complex process and manufacturing challenges.
• Apply advanced statistical analysis and predictive-modeling tools to evaluate process performance, identify emerging trends, predict manufacturing outcomes, and support data-driven decisions 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 the preparation of responses to regulatory observations.
• Mentor junior scientists and engineers while providing technical leadership across programs and project teams.
• Help strengthen organizational capabilities and establish downstream purification best practices across development and manufacturing programs.

Qualifications

One of the following combinations of education and relevant pharmaceutical or biotechnology industry experience:

• PhD in Bioengineering, Chemical Engineering, Microbiology, Chemistry, Biochemistry, or a related discipline with at least eight years of relevant industry experience;
• Master’s degree in one of these disciplines with at least 13 years of relevant industry experience; or
• Bachelor’s degree in one of these disciplines with at least 16 years of relevant industry experience.

• Extensive experience with downstream purification process development, process characterization, technology transfer, scale-up, and GMP manufacturing support.
• Strong technical expertise in chromatography, filtration, UF/DF, and related downstream processing operations.
• Experience supporting GMP manufacturing and late-stage clinical or commercial manufacturing programs.
• Experience with process validation and lifecycle process management, including PPQ and CPV programs.
• Demonstrated experience applying statistical analysis, multivariate data analysis, and predictive-modeling techniques to process characterization, technology transfer, process validation, CPV, and manufacturing-process monitoring.
• Experience leading complex technical deviations, investigations, troubleshooting activities, and root-cause analyses.
• Experience working with CMOs and other external manufacturing partners.
• Hands-on experience with laboratory-scale and pilot-scale purification operations.
• Strong knowledge of current Good Manufacturing Practice regulations and manufacturing quality and compliance systems.
• Excellent communication, technical writing, presentation, project-management, and cross-functional leadership skills.
• Demonstrated ability to influence and guide matrixed teams without direct authority.

Preferred Qualifications

• 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.

Pay

The anticipated base salary range for this position is $186,000-$218,000 for candidates located in the San Francisco Bay Area. The complete compensation package is expected to include comprehensive benefits and an equity component. Final compensation will depend on relevant experience, qualifications, specialized expertise, and other job-related considerations.

Schedule

Onsite, a minimum of four days per week.