Process Development Senior Associate (Attribute Sciences)

Career Category

Scientific

Job Description

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.
• 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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. . The collaborative professional we seek is a motivated, self-starter with these qualifications

Basic Qualifications:

• 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

Preferred Qualifications:

• 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

86,613.00 USD - 104,742.00 USD