Process Development Sr Associate - 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 Sr Associate - Drug Product Technologies

What you will do

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

The Pivotal Drug Product Technologies organization at Amgen develops, characterizes, and supports the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio.

Amgen is currently seeking a Process Development Senior Associate for our 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 large molecule modalities (e.g., monoclonal antibodies, bispecific T-cell engagers (BiTEs), fusion proteins, etc.). The Senior Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product commercialization and lifecycle management.

Responsibilities include:

• Utilize high throughput technologies and automation platforms in the execution of formulation and process development studies.

• Identify and implement innovative solutions to increase throughput, improve quality, and streamline data capture and analysis.

• Participate in the planning, design, and execution of formulation and process development studies by applying basic science/engineering skills and prior knowledge.

• Evaluate product and process performance through analytical testing (e.g., U/HPLC, particle analysis, moisture content, physical properties, etc.) and perform subsequent data analysis and method compliance assessments as appropriate.

• Demonstrate technical writing and data integrity in authoring and data verifying technical protocols and reports, electronic laboratory notebooks, and regulatory documents.

• Participate in team meetings by sharing study designs, results, and technical challenges.

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 an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 6 years of Scientific, Engineering, or Operations experience OR

• Associate’s degree and 4 years of Scientific, Engineering, or Operations experience OR

• Bachelor’s degree and 2 years of Scientific, Engineering, or Operations experience OR

• Master’s degree

Preferred Qualifications:

• Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics, or related subject area.

• 1+ years of experience in pharmaceuticals/biotechnology that includes high throughput methodologies, process characterization, formulation development, and equipment implementation.

• Familiar and proficient in operating high throughput technologies (e.g., plate-based liquid handling, and analytical testing) and workflow execution, as well as the subsequent analysis of resulting data.

• Familiarity with pharmaceutical/biotechnology process development. Knowledge of Drug Product unit operations and experience with relevant analytical techniques.

• Understanding of physical/chemical stability of proteins and how formulation and process-related stresses impact molecule attributes and product quality.

• Proficiency in data analysis and processing.

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, and follow instructions, while aligning with guidance and compliance requirements.

• Demonstrated strong communication skills and ability to mult