Microbiology Process Development Specialist

Amgen Inc. (IR); Thousand Oaks, Northern (CA, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Amgen Inc. (IR) in Thousand Oaks, CA, seeks a Process Development Associate in Microbiology to execute microbiological method development studies, contribute to troubleshooting, and support data analysis and reporting.

The role emphasizes collaboration with QC Microbiology, Process Development, Manufacturing, and Quality teams. The successful candidate will apply aseptic techniques, interpret data, and assist with protocols and summaries while staying current with regulatory guidance (USP, Ph.

Qualifications

• Bachelor’s degree or Associate’s degree with 4 years microbiology experience or HS diploma with 6 years microbiology experience.
• Hands-on experience in microbiology and aseptic techniques.
• Experience with compendial microbiological methods, including bioburden, endotoxins, and/or sterility testing.
• Detail-oriented with strong laboratory documentation and technical writing skills.
• Ability to independently organize and execute laboratory studies while managing multiple priorities and timelines.
• Proficiency with SharePoint and Smartsheet.

Responsibilities

• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, and validation.
• Analyze and interpret experimental data; summarize study results; assist with protocols and reports.
• Maintain knowledge of compendial requirements (USP, Ph. Eur., JP, CFRs).
• Collaborate with QC Microbiology, Process Development, Manufacturing, and Quality.
• Represent Process Microbiology in meetings and communicate progress and findings.
• Support day-to-day laboratory operations, supplies, and inventory.

Skills

Microbiology

Aseptic techniques

Data analysis

Documentation

SharePoint

Smartsheet

Education

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

USP/Ph. Eur./JP knowledge

Job description

Amgen Inc. (IR) in Thousand Oaks, CA, seeks a Process Development Associate in Microbiology to execute microbiological method development studies, contribute to troubleshooting, and support data analysis and reporting.

The role emphasizes collaboration with QC Microbiology, Process Development, Manufacturing, and Quality teams. The successful candidate will apply aseptic techniques, interpret data, and assist with protocols and summaries while staying current with regulatory guidance (USP, Ph.