Biotech Downstream Drug Substance Process Engineer

Amgen; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Amgen seeks an Engineer for the Drug Substance Technology & Engineering team in Thousand Oaks, CA. The role provides downstream purification process engineering support across clinical and commercial biologics, including technology transfer and process validation in a cGMP environment.

You will collaborate with multiple teams to translate development processes into scalable manufacturing, delivering safe, effective medicines while supporting continuous improvement and on-the-floor

Qualifications

• Master's degree is required.
• Bachelor's degree with 2 years of Process Development experience.
• Associate's degree with 6 years of Process Development experience.
• High school diploma / GED with 8 years of Process Development experience.

Responsibilities

• Transfer purification drug substance processes and process improvements from the laboratory to manufacturing facilities and between manufacturing sites.
• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision; seek assistance when addressing unusual problems.
• Support process validation for late-stage commercial processes.
• Provide on-the-floor technical support for process scale-up and technology transfer, as well as clinical and commercial manufacturing operations.
• Trend process data and perform statistical analyses.
• Identify and support process-related operational excellence and continuous improvement opportunities.

Education

Master's degree

Bachelor's degree and 2 years of Process Development experience

Associate's degree and 6 years of Process Development experience

High school diploma / GED and 8 years of Process Development

Job description

Amgen seeks an Engineer for the Drug Substance Technology & Engineering team in Thousand Oaks, CA. The role provides downstream purification process engineering support across clinical and commercial biologics, including technology transfer and process validation in a cGMP environment.

You will collaborate with multiple teams to translate development processes into scalable manufacturing, delivering safe, effective medicines while supporting continuous improvement and on-the-floor