Process Development Senior Associate (Attribute Sciences)

Amgen

1d

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. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Process Development Senior 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.

Requirements

• High school diploma / GED and 6 years of Process Development / Chemistry or related experience OR Associate’s degree and 4 years of Process Development / Chemistry or related experience OR Bachelor’s degree and 2 years of Process Development / Chemistry or related experience OR Master’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.
• Strong experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis) and Chromatography (SE and RP)).
• Experience in method transfers, method validation, method troubleshooting, and complex investigations.
• Familiarity with and understanding of 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.
• Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level