Staff Engineer​/Consultant, Downstream Process Development & Manufacturing

Viltis is seeking an experienced downstream process development professional to support a clinical-stage vaccine company advancing innovative vaccines against serious bacterial diseases.

This contract position will provide technical leadership across downstream purification, technology transfer, commercial scale-up, process validation, and GMP manufacturing support.
Downstream process development and commercial scale-up experience within a vaccine company are strongly preferred.

The consultant will partner with internal teams and Contract Manufacturing Organizations (CMOs) to support the transfer, scale-up, validation, and execution of downstream protein purification processes.

Initial priorities include technology transfer, manufacturing readiness, process validation, and commercialization support. Depending on program needs, the assignment may also include process optimization, scale-down model development, process characterization, pilot-scale studies, and lifecycle improvements.

• Lead downstream purification technology transfer and scale-up 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 in chromatography, filtration, ultrafiltration/diafiltration (UF/DF), and related downstream purification operations.
• Design, support, and analyze laboratory-scale and pilot-scale studies for process characterization, comparability, validation, and troubleshooting.
• Apply statistical analysis, multivariate data analysis, and predictive modeling to evaluate process performance and support manufacturing decisions.
• Partner with CMOs and cross-functional stakeholders to support manufacturing readiness, regulatory compliance, and successful process execution.
• Lead technical troubleshooting, deviations, investigations, root-cause analyses, and risk assessments.
• Identify opportunities to improve process robustness, scalability, yield, and manufacturing performance.
• Author and review technical reports, technology-transfer documentation, validation protocols, regulatory-support documents, and technical assessments.
• Support inspection readiness and responses to regulatory observations.
• Provide technical guidance to scientists, engineers, and project teams.

• 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 a related discipline with at least 13 years of relevant industry experience; or
  • Bachelor's degree in a related discipline with at least 16 years of relevant industry experience.
• Extensive experience in downstream purification process development, process characterization, technology transfer, scale-up, and GMP manufacturing support.
• Strong technical expertise in chromatography, filtration, and UF/DF.
• Experience supporting late-stage clinical or commercial manufacturing programs.
• Experience with process validation and lifecycle management, including PPQ and CPV.
• Demonstrated application of statistical analysis, multivariate data analysis, and predictive modeling to process development and manufacturing.
• Experience leading complex technical investigations and root-cause analyses.
• Experience working with CMOs or external manufacturing partners.
• Hands-on laboratory-scale and pilot-scale purification experience.
• Strong knowledge of current Good Manufacturing Practice requirements and manufacturing quality systems.
• Excellent technical writing, communication, project-management, and cross-functional collaboration skills.
• Ability to guide matrixed teams and independently manage technical priorities.

• Downstream process development and commercial scale-up experience within a vaccine company.
• Experience with vaccine, protein, or conjugate manufacturing processes.
• Experience supporting commercialization, regulatory filings, and health-authority inspections.
• Experience implementing or supporting transitional analysis for chromatography column integrity testing.

The pay range for this contract assignment is $80-100 per hour
, depending on relevant experience, qualifications, and…