Process Development Associate (Attribute Sciences)

Role Summary

The Process Development Associate (Attribute Sciences) is a laboratory-based role within Amgen’s Attribute Sciences and Process Development organization. The position focuses on evaluating material attributes and analytical testing to support development, transfer, investigation, and continuous improvement efforts at the FleX Batch facility. The role requires scientific and technical contributions to define favorable quality characteristics and to optimize analytical tools guiding development.

Responsibilities

• Deliver rapid and robust analytical testing to site, process development team, and quality control.
• Provide analysis support for small-scale model transfers, method transfers, investigation support, and continuous improvements.
• Collaborate with functions including Drug Substance, Quality, and Manufacturing.
• Utilize analytical methodologies to detect product quality attributes and process-related impurities using techniques such as UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
• Execute methods, author reports, and ensure safety and compliance for all activities.

Qualifications

• Required: High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
• Required: Associate‚Äôs degree and 2 years of Process Development / Chemistry or related experience OR
• Required: Bachelor‚Äôs degree
• Preferred: Degree in Chemistry or related area.
• Preferred: Experience in pharmaceutical process development with analytical support, execution of methods, and investigational testing.
• Preferred: Experience in single or multiple analytical techniques (CE, ELISA, DNA, Chromatography, PCR).
• Preferred: Experience in method transfers, method validation, and method troubleshooting.
• Preferred: Familiarity with USP monographs/ICH/FDA documents related to analytical method transfer and validation.
• Preferred: Effective oral and verbal communication skills.
• Preferred: Technical writing skills and attention to detail.
• Preferred: Self-starter and valuable teammate.