Manufacturing Associate, Pilot Plant - Upstream

Role Summary

The Manufacturing Associate, Pilot Plant - Upstream is an entry-level position responsible for implementing a variety of production and technology-related operations in a large-scale Pilot Plant Upstream (cell culture) environment. The Pilot Plant delivers data and material supporting process development of early- and late-stage clinical biologic molecules and prototypes new technologies to advance Amgen’s current and future biologics manufacturing capabilities. You will work in a fast-paced environment to support innovation and scale-up of biologics processes.

Responsibilities

• Perform hands-on operation of current and future cell culture equipment, including: Wave bioreactors, stainless steel and single-use bioreactors, ATFs and associated equipment cleaning, and support pilot-scale upstream processes from scale-up through harvest
• Execute production runs, experiments, and technology development activities
• Support new product introductions (NPI) and technology transfer
• Participate in equipment commissioning and equipment design
• Design experiments and analyze process data
• Document work through Standard Operating Procedures (SOPs), electronic lab notebooks, manufacturing procedures, and presentations or meeting notes
• Summarize findings, identify process challenges, and support future commercial process development
• Work in a fast-paced, hands-on Pilot Plant manufacturing environment
• Interact with upstream process development, NPI, and operations teams
• Focus on innovation, scalability, and technology advancement for biologics manufacturing
• Work off-hours or non-standard shifts as required by production schedules

Qualifications

• Required: High school diploma / GED and 2 years of Manufacturing, Scientific or Operations experience; Or Associate’s degree and 6 months of Manufacturing, Scientific or Operations experience; Or Bachelor’s degree
• Preferred: Strong verbal and written communication skills
• Preferred: Demonstrated analytical, project management, and continuous improvement abilities
• Preferred: Experience working in GMP / GDP-regulated environments
• Preferred: Ability to work off-hours or alternative shifts