Upstream Drug Substance Engineer – Tech Transfer & Scale-Up

Amgen Inc.; Thousand Oaks (CA); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen Inc. is seeking an Engineer to join the Drug Substance Technologies and Engineering team at Thousand Oaks. The role focuses on technology transfer and process validation for human therapeutic biologics across clinical and commercial manufacturing spaces.

The candidate will transfer cell culture drug-substance processes, support late-stage validation, and provide on-floor technical support for scale-up and transfer, while collaborating with Manufacturing, Quality, and Regulatory teams.

Qualifications

• Master’s or Bachelor’s with PD experience in process development.
• Upstream cell culture and purification knowledge for biologics (cGMP).
• Experience with large-scale GMP manufacturing and tech transfers.

Responsibilities

• Transfer cell culture drug-substance processes into manufacturing and between sites.
• Support late-stage process validation for commercial processes.
• Provide on-floor technical support for scale-up and tech transfer.
• Conduct routine process monitoring and troubleshooting.
• Analyze data trends and contribute to deviations and CAPAs.

Skills

Cell culture

Process engineering

Biochemical engineering

Analytical skills

Technical writing

Education

Master’s degree in Chemical Engineering

Bachelor’s degree in Engineering or related

Tools

Chromatography

Ultrafiltration

Process validation

Job description

Amgen Inc. is seeking an Engineer to join the Drug Substance Technologies and Engineering team at Thousand Oaks. The role focuses on technology transfer and process validation for human therapeutic biologics across clinical and commercial manufacturing spaces.

The candidate will transfer cell culture drug-substance processes, support late-stage validation, and provide on-floor technical support for scale-up and transfer, while collaborating with Manufacturing, Quality, and Regulatory teams.