Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Amgen is currently seeking a Process Development Associate Scientist for the Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities. The Associate Scientist will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product commercialization and lifecycle management. Additionally, the position will require support of Lab activities and assets.

What you will do

Let’s do this. Let’s change the world.

• Plan, design, implement, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management

• Apply basic science/engineering skills and first principles modeling to solve technical problems

• The position will require support of Lab activities and assets

• 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 technical protocols, reports, and regulatory sections in support of INDa and marketing application submissions.

• Contribute to progress reports and presentations to management on technical challenges, proposed solutions and results

Basic Qualifications

• Master’s degree

Or

• Bachelor’s degree and 2 years of scientific experience

Preferred Qualifications:

• Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related subject area.

• Industry experience in pharmaceuticals/biotechnology Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.

• Experience with data visualization tools or packages, such as Tableau or Spotfire.

• Experience that includes elements of new product development, formulation development, process characterization, lab asset management, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.

• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability

• Ability to learn and act on dynamic information at a rapid pace.

• Strong organizational skills with attention to detail

• Excellent communication (oral and written)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is an employee with these qualifications.

• Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related field.

• 2+ years industry experience in pharmaceuticals/biotechnology

• Some experience in handling laboratory asset management

• Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up

• 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.

• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability

• Ability to learn and act on dynamic information at a rapid pace.

• Strong organizational skills with attention to detail

• Excellent communication (oral and written)

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com