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 !

In this vital role you will provide technical and project leadership, integrating effective cross functional collaboration, to ensure success for commercial programs and lifecycle management. As a Process Development Principal Scientist, ASTL (Attribute Sciences Team Lead), you will be a member of the Commercial Attribute Sciences group where the responsibilities include:

• Responsible for analytical leadership of a commercial program(s) including method lifecycle management, method qualification, transfer, validation and remediation.

• Represent Attribute Sciences as a core member of Product Delivery Team(s)

• Provide analytical subject matter expert technical support to commercial testing, stability programs and manufacturing operations.

• Interact and collaborate with global cross-functional team that includes Drug Substance and Drug Product operations, Quality, Regulatory CMC and Supply Chain.

• As ASTL, will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success of the commercial portfolio.

What we expect of you

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

Basic Qualifications:

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

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

• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific or Operations experience

Preferred Qualifications:

• Scientist with 5+ years of experience in providing and driving analytical deliverables for biopharmaceutical processes and product development.

• Deep understanding of product quality attributes control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.

• Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing using HPLC, CE, LC/MS, ELISA, and/or other techniques.

• Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.

• Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.

• Understanding of biopharmaceutical manufacturing processes.

• Demonstrated experience working in matrix environment.

• Experience in technical transfer for GMP production and testing to external contract organizations, able to manage deliverables against timelines.

• Experience in data analysis, statistical analysis, setting acceptance criteria, comparability studies, and process/method transfers.

• Experience in applying troubleshooting and investigation methodologies.

• Strong project management skills, including the ability to manage one’s project resources.

• Strong organizational skills with attention to detail.

• Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally.

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