Senior Engineer, Downstream Drug Substance Tech & Transfer

Amgen; Thousand Oaks (CA); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen Inc. seeks a Senior Engineer to provide downstream purification manufacturing support for a diverse portfolio of clinical and commercial biologics.

You will lead engineering oversight, support technology transfer, process optimization, and manufacturing execution across development and commercialization lifecycles. You will manage and mentor downstream engineers, work with cross‑functional teams, ensure cGMP compliance, and drive investigations, CAPAs, and process improvements.

Qualifications

• Doctorate or Master’s degree with engineering experience in downstream purification or related field.
• Experience leading tech transfer for biologics or complex manufacturing processes.
• Strong knowledge of cGMP, regulatory filings, and quality systems.
• Proven ability to lead cross‑functional teams and manage engineers.
• Experience with investigations, CAPAs, and risk assessment is a plus.

Responsibilities

• Lead downstream purification processes: harvest, clarification, chromatography, filtration.
• Provide engineering oversight and support tech transfer and manufacturing readiness.
• Mentor and develop junior engineers in process knowledge and troubleshooting.
• Collaborate with Manufacturing, Quality, Process Development, Validation, and Regulatory teams.
• Drive process optimization, data analysis, and DOE studies to improve yield and quality.
• Support regulatory filings and inspections as needed.

Skills

Downstream purification

Tech transfer

Process validation

GMP compliance

Regulatory filings

Root cause analysis

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Process Modeling

Process Analytical Technology

Statistical software

Job description

Amgen Inc. seeks a Senior Engineer to provide downstream purification manufacturing support for a diverse portfolio of clinical and commercial biologics.

You will lead engineering oversight, support technology transfer, process optimization, and manufacturing execution across development and commercialization lifecycles. You will manage and mentor downstream engineers, work with cross‑functional teams, ensure cGMP compliance, and drive investigations, CAPAs, and process improvements.