Staff Engineer: Downstream Process Development & Manufacturing

Viltis; San Carlos, Northern (CA, KY); Hybrid; USD 186,000 - 218,000; Full time

Job summary

Viltis is seeking a Staff Engineer to lead downstream purification, process development, and technology transfer for protein manufacturing programs.

The role involves collaboration with CMOs, site manufacturing teams, and internal stakeholders to ensure transfer, validation, and commercial execution of purification processes.

Ideal candidates will have deep expertise in chromatography, filtration, UF/DF, and experience in regulatory-compliant manufacturing environments.

Qualifications

• PhD in Bioengineering, Chemical Engineering, Microbiology, Chemistry, Biochemistry or related field with at least eight years of industry experience.
• MS with at least 13 years of industry experience.
• BS with at least 16 years of industry experience.
• Extensive experience with downstream purification process development, characterization, technology transfer, scale-up, and GMP manufacturing support.
• Strong expertise in chromatography, filtration, UF/DF, and related downstream processing operations.
• Experience supporting GMP manufacturing and late-stage clinical or commercial programs.
• Experience with process validation and lifecycle management including PPQ and CPV.

Responsibilities

• Provide technical leadership across downstream purification, tech transfer, validation, and GMP manufacturing support.
• Lead technology transfer and scale-up activities from development to GMP facilities.
• Serve as a technical authority for downstream purification; guide cross-functional teams.
• Support CPV, PPQ, and lifecycle process management with robust data.
• Collaborate with CMOs and internal stakeholders to ensure successful manufacturing transfer.
• Drive continuous-improvement and risk mitigation in downstream processes.

Skills

Downstream purification

Technology transfer

GMP manufacturing

Process development

Data analysis

Cross-functional leadership

Statistical analysis

Education

PhD in Bioengineering/Chemical Engineering/Microbiology

MS in a related discipline

BS in a related discipline

Job description

Viltis is seeking a Staff Engineer to lead downstream purification, process development, and technology transfer for protein manufacturing programs.

The role involves collaboration with CMOs, site manufacturing teams, and internal stakeholders to ensure transfer, validation, and commercial execution of purification processes.

Ideal candidates will have deep expertise in chromatography, filtration, UF/DF, and experience in regulatory-compliant manufacturing environments.