Sr. Associate (Process Development)

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.

Sr. Associate (Process Development)

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) and fusion proteins). The Sr. 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:

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

• Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)

• Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)

• Author and data verify technical protocols and reports

• Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)

• Author/review technical protocols and reports

• 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 process characterization, formulation development, equipment design and implementation, technology transfers

• Familiarity with pharmaceutical/biotechnology process development

• Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)

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

• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies

• Self-motivation, adaptability and a positive attitude

• Critical thinking, problem solving and independent research skills

• Good organizational skills with strong attention to detail

• Excellent communication (oral and written)

What you can expect of us

As we work to develop treatments that take care of others, we also work to car