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Manufacturing Associate Pilot Plant - Downstream

Amgen
On-site
Thousand Oaks, CA
Operations

Role Summary

Pilot Plant Manufacturing Associate in the Downstream (Purification) area of a large-scale pilot plant. You will execute production and technology-related operations to support process development of clinical biologic molecules, prototype new technologies, and contribute to equipment advancement for current and future facilities. You will perform hands-on purification operations and document results to support future commercial processes.

Responsibilities

  • Perform hands-on operations of purification equipment, including large scale chromatography, various types of filtration, ultrafiltration/diafiltration, and equipment cleaning.
  • Participate in new product introductions, technology transfer, experiment design, equipment commissioning, and equipment design.
  • Communicate results through authoring standard operating procedures, detailing results in electronic lab notebooks, manufacturing procedures, presentations, or meeting notes.
  • Analyze data, process results, summarize findings, and identify challenges to future commercial processes.
  • Must be able to work both Day (7:30am - 4:30pm) and Swing Shift (2:30pm - 11:30pm). Shifts rotate roughly every 3 months based on business needs.
  • Ability to lift and move up to 25 lbs.
  • Complete a variety of production-related operations in a large-scale facility, including chromatography, UF/DF, and viral filtration; perform supporting activities such as equipment set-up/cleaning and running analytical instruments; and perform hands-on work in the plant.
  • Ensure documentation accurately reflects operations performed, implement area improvements (efficiency and safety) applying lean principles, and participate in operations meetings.

Qualifications

  • Basic Qualifications: 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 Qualifications: Bachelor’s degree and previous bio-processing/biotech experience; strong verbal and written communication skills; analytical, project management, and continuous improvement skills; ability to work off hours or non-standard shifts.