Process Development Senior Associate

** 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Associate*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role you will join 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:*
* + 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)

+ Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet

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

+ Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.

+ 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 employee with these qualifications.

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* Basic Qualifications:

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* Master's degree

OR

Bachelor's degree and 2 years of Scientific experience

OR

Associate's degree and 4 years of Scientific experience

OR

High school diploma / GED and 6 years of Scientific experience

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* Preferred Qualifications:

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* + Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related field

+ 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)

+

Experience with progr…