Process Development Associate - LM Release Testing

Amgen; Thousand Oaks (CA); On-site; USD 75,000 - 101,000; Full time

Job summary

Amgen seeks a Process Development Associate – Large Molecule Release Testing in Thousand Oaks, CA, to define critical quality attributes and advance analytical tools supporting biologics development. You will work in a GMP setting within LMRT, collaborating with cross-functional partners on method co-development and transfer.

The role requires a scientific background with experience in cell culture, bioassays, and analytical methods, plus strong documentation and teamwork to ensure quality and

Qualifications

• Bachelor’s or higher in a related scientific field with relevant biotech experience.
• Experience with GxP regulations and biotech industry standards.
• Ability to develop, qualify, and test analytical methods.
• Strong teamwork and precise documentation in GMP environments.
• Excellent communication skills, both written and oral.

Responsibilities

• Define quality attributes for Amgen therapies and support analytical method development.
• Collaborate on co-development, co-qualification, and method transfer activities.
• Maintain cell culture, prep reagents/media/buffer, and support lab operations.
• Perform cell-based assays, ELISA, qPCR, and data generation with validation.
• Assist in data organization, reporting, and troubleshooting of methods.
• Manage reagents inventory and ensure audit readiness.

Skills

Cell culture

Cell-based bioassay

Binding assays

Immunoassays

qPCR

Documentation

Education

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen seeks a Process Development Associate – Large Molecule Release Testing in Thousand Oaks, CA, to define critical quality attributes and advance analytical tools supporting biologics development. You will work in a GMP setting within LMRT, collaborating with cross-functional partners on method co-development and transfer.

The role requires a scientific background with experience in cell culture, bioassays, and analytical methods, plus strong documentation and teamwork to ensure quality and