Staff Engineer – Downstream Purification & Process Transfer

Vaxcyte

San Carlos (CA)

On-site

USD 186,000 - 218,000

Full time

9 days ago

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Job summary

Vaxcyte is seeking a highly motivated Staff Engineer to lead downstream purification and technology transfer from development to GMP manufacturing. The role involves handling process validation, CPV, and lifecycle management across clinical and commercial programs.

The successful candidate will partner with CMOs and internal stakeholders, apply advanced statistics, and guide cross-functional teams through critical manufacturing decisions.

Qualifications

PhD with 8+ years pharma/biotech experience or equivalent.
Extensive experience in downstream purification, transfer, scale-up, and GMP support.
Strong chromatography, filtration, UF/DF expertise.

Responsibilities

Lead downstream purification tech transfer and scale-up to GMP facilities.
Provide technical support for GMP campaigns, PPQ, CPV, and lifecycle management.
Serve as SME in downstream purification including chromatography, filtration, UF/DF, scale-up, and characterization.
Design and execute pilot-scale studies for characterization and validation strategies.
Mentor junior scientists and collaborate with CMOs and cross-functional teams.

Skills

Downstream purification

Chromatography

Filtration

UF/DF

Technology transfer

Process validation

Data analysis

Regulatory awareness

Education

PhD in Bio/Chemical Engineering or related

Master’s degree in Bio/Chemical Engineering or related

Bachelor’s degree with extensive pharma/biotech experience

Tools

GMP manufacturing systems

Statistical modeling tools

Job description

The successful candidate will partner with CMOs and internal stakeholders, apply advanced statistics, and guide cross-functional teams through critical manufacturing decisions.

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