Process Development Principal Scientist

Career Category

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.

Process Development Principal Scientist

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. We focus on the attributes of our therapies define favorable quality characteristics while optimizing innovative analytical tools.

In this vital role, you will work to provide scientific 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, process development support, and method troubleshooting.

• Lead the successful completion of technical projects and the development of innovative technologies, serving as a scientific expert and project leader.

• Collaborate cross-functionally to deliver analytical support for manufacturing and testing.

• Solve complex problems independently with creativity and ingenuity.

• Serve as a technical resource for multiple analytical methodologies to assess product quality attributes and process-related impurities, including techniques such as UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.

• Evaluate and enhance Amgen’s platform and analytical technologies to drive innovation and efficiency in Process Development.

• Present scientific and technical findings effectively in both formal and informal settings.

• Apply your knowledge of drug development processes to guide project teams and contribute to program strategies.

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:

• Bachelor’s degree and 7 years of Scientific experience OR

• Master’s degree and 5 years of Scientific experience OR

• Doctorate degree PhD OR PharmD OR MD and relevant post-doc where applicable and 2 years of Scientific experience.

Preferred Qualifications:

• Advanced degree in Analytical Chemistry or a biopharmaceutical-related area.

• Four or more years of experience in pharmaceutical process development, focusing on analytical support, method execution, and drug manufacturing.

• Expertise in complex analytical problem solving, statistical analysis, and evaluating product quality attributes related to biological processing.

• Experience in method transfers, validation, troubleshooting, and addressing complex investigations.

• Strong knowledge of United States Pharmacopeia (USP) monographs and chapters, as well as International Conference on Harmonization (ICH) and FDA guidance.

• Excellent technical writing skills with strong attention to detail in reports and documentation.

• Effective communicator who interacts well with diverse internal and external stakeholders and provides cross-functional leadership and mentorship.

• A proactive team leader, self-starter, and decision-maker with the ability to mentor staff at various levels.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based