Downstream Process Engineer, Biologics Drug Substance

Amgen; Thousand Oaks (CA); Presencial; USD 88.000 - 119.000; Jornada completa

Descripción de la vacante

Amgen’s Thousand Oaks site seeks an Engineer to support downstream purification and biologics drug substance manufacturing. You will partner with cross-functional teams to transfer processes from lab to manufacturing and contribute to process validation for late-stage programs.

You will apply engineering principles, statistics, and problem-solving to improve unit operations, support scale-up, and ensure compliant, reliable production of clinical and commercial products.

Formación

• Master’s degree or Bachelor’s degree with 2+ years of Process Development experience.
• Associate’s degree with 6+ years of Process Development experience may qualify.
• High school diploma with 8+ years of Process Development experience accepted.

Responsabilidades

• Transfer purification drug substance processes from lab to manufacturing facilities and between sites.
• Provide on-the-floor technical support for process scale-up and tech transfer.
• Support process validation for late-stage commercial processes.
• Trend process data and perform statistical analyses.
• Collaborate with Manufacturing, Quality, Regulatory, Research, and Maintenance teams to develop requirements.

Conocimientos

Downstream purification

Process engineering

Technology transfer

cGMP manufacturing

Statistical analysis

Educación

Master’s degree

Bachelor’s degree

Associate degree

High school diploma

Herramientas

Chromatography

Ultrafiltration

Viral inactivation

Descripción del empleo

Amgen’s Thousand Oaks site seeks an Engineer to support downstream purification and biologics drug substance manufacturing. You will partner with cross-functional teams to transfer processes from lab to manufacturing and contribute to process validation for late-stage programs.

You will apply engineering principles, statistics, and problem-solving to improve unit operations, support scale-up, and ensure compliant, reliable production of clinical and commercial products.