Biologics Process Development Associate – Characterization

Amgen; Thousand Oaks (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

Amgen is seeking a Process Development Associate – Biological and Structural Characterization in Thousand Oaks to advance analytical method development for potency, release, and stability. You will contribute to product characterization, investigations, and regulatory submissions.

The role requires hands-on cell culture and bioassay experience, strong data analysis, and collaboration with development and quality teams.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• Experience with cell culture and bioassay characterization is highly desired.
• Strong documentation and data interpretation skills are essential.

Responsibilities

• Implement analytical potency methods for release, stability, and characterization.
• Prepare technical reports for investigations, product/impurity characterization, and regulatory filings.
• Generate and analyze analytical data to support product development and regulatory submissions.
• Collaborate with product/process development and quality teams, providing updates and data interpretation.

Skills

Cell culture

Bioassay development

Signal transduction

Gene expression

Fluorescent probes

Attention to detail

Documentation

Automation (liquid handling)

Communication

Client relationships

Education

Bachelor's degree in Science

Job description

Amgen is seeking a Process Development Associate – Biological and Structural Characterization in Thousand Oaks to advance analytical method development for potency, release, and stability. You will contribute to product characterization, investigations, and regulatory submissions.

The role requires hands-on cell culture and bioassay experience, strong data analysis, and collaboration with development and quality teams.