Process Development Senior Associate (Attribute Sciences)

Role Summary

Role within Amgen’s Attribute Sciences (AS) department in the Process Development (PD) organization that defines favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. This laboratory-based role will evaluate attributes of materials based on multiple analytical techniques, focusing on analytical testing, support, and troubleshooting at Amgen’s FleX Batch facility.

Responsibilities

• Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
• Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
• Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
• Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to chromatography, capillary electrophoresis, and UV-Vis spectroscopy.
• Execute methods, author reports and ensure safety and compliance for all activities.

Qualifications

• Required: High school diploma / GED and 6 years of Process Development / Chemistry or related experience
• Required: Associate’s degree and 4 years of Process Development / Chemistry or related experience
• Required: Bachelor’s degree and 2 years of Process Development / Chemistry or related experience
• Required: Master’s degree
• Preferred: Degree in Chemistry or related area.
• Preferred: Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
• Preferred: Strong experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis) and Chromatography (SE and RP)).
• Preferred: Experience in method transfers, method validation, method troubleshooting, and complex investigations.
• Preferred: Familiarity with and understanding of USP monographs and chapters, and ICH / FDA mentorship documents related to analytical method transfer and validation.
• Preferred: Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing.

Skills

• Oral and verbal communication skills, interact effectively with diverse internal and external stakeholders.
• Excellent technical writing skills and attention to details in documents.
• A self-starter and valuable teammate.