Process Development Associate (Attribute Sciences)

Amgen•Holly Springs, NC

1d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Process Development Associate (Attribute Sciences) What you will do Let’s do this. Let’s change the world. This role is part of Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting. 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 UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR. Execute methods, author reports and ensure safety and compliance for all activities. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Requirements

High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR Associate’s degree and 2 years of Process Development / Chemistry or related experience OR Bachelor’s degree

Nice To Haves

Degree in Chemistry or related area.
Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR).
Experience in method transfers, method validation, and method troubleshooting.
Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
Effective oral and verbal communication skills.
Technical writing skills and attention to details in documents.
A self-starter and valuable teammate.

Responsibilities

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 UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
Execute methods, author reports and ensure safety and compliance for all activities.