Process Development Senior Scientist - Pivotal Drug Product Technologies

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 Senior Scientist - Pivotal Drug Product Technologies

What you will do

Let’s do this. Let’s change the world. In this vital role you are responsible for late stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). Additionally, the position works on ways to enhance how data is analyzed and the use of statistical models to inform decisions throughout drug product development. The Sr. Scientist role involves providing technical and project leadership while integrating information generated by cross-functional teams to ensure success through the commercialization process.

Responsibilities:

• Apply basic science/engineering skills and first principle modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
• Ability to travel domestically and internationally up to 10% of the time

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD completed by May 2025

Or

Master’s degree and 3 years of scientific experience

Or

Bachelor’s degree and 5 years of scientific experience

Preferred Qualifications:

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related discipline with experience in pharmaceutical development and manufacturing
• 2+ years of post-doctoral or industry experience in pharmaceuticals/biotechnology or related field
• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
• Experience leveraging Artificial Intelligence (AI) and Generative AI (GenAI) tools to drive automation, enhance data analysis, optimize workflows, and develop AI-powered solutions for business and operational efficiency
• Strong problem solving and effective cross-functional communication skills
• Experience with data visualization tools or packages, such as Tableau or Spotfire
• Experience that includes elements of new product development, formulation development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Proven ability to learn and act on dynamic information at a rapid pace

What you can expect from 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