Process Development Associate Scientist - Pre-Pivotal Drug Product Technologies

** 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 Associate Scientist*
* ** What you will do*
* Let's do this. Let's change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on monoclonal antibodies, multispecifics and other biologic modalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs); establishing robust, scalable fill/finish processes for complex biologic drug products;

and authoring and supporting high quality regulatory submissions.

+ Plan and execute formulation, stability, end-use compatibility, and fill/finish process studies for early-stage programs.

+ Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on biologics drug product formulation, handling, and lab-scale sterile filling.

+ Investigate biologics-relevant CQAs (e.g., aggregation, fragmentation, charge/size variants, subvisible particles, surface interactions) to inform formulation and process design decisions.

+ Design, develop, and execute automated high-throughput formulation screening workflows to accelerate excipient selection, formulation optimization, and processability assessments.

+ Develop and implement laboratory automation solutions, including robotic liquid handling systems and automated sample preparation workflows, to improve experimental throughput, reproducibility, and data quality.

+ Utilize design of experiments (DoE), high-throughput experimentation, and automated data analysis pipelines to efficiently explore formulation design space and support data-driven decision making.

+ Identify and address technology gaps impacting biologics stability, protein-excipient interactions, and process-related stress responses.

+ Apply machine learning, AI, laboratory automation, and data science to predictive modeling, workflow acceleration, and decision-making.

+ Author/review guideline documents, technical protocols, technical transfer documentation, reports, product impact assessments, and regulatory sections in support of IND submissions

+ Meticulous data collection, documentation using electronic data capture systems

+ Ability to work in a matrixed team and present data cross functionally

** 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 leader with these qualifications.

*
* Basic Qualifications:

*
* 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

*
* Preferred Qualifications:

*
* + Master's degree in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry, Biophysics, Chemical Engineering, or related field with a minimum of 3+ years of industrial experience in pharmaceutical/biotechnology or related field

+ Understanding of physical/chemical stability of proteins and how process related stress impacts product quality.

+ Preferred experience in biophysical analysis (Light scattering, DSF, AUC, FFF) and mass spectrometry (peptide mapping).

+ Ability to learn and act on dynamic information at a rapid pace, hard-working and collaborative attitude

+ Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results for a fast pace and cross functional environment.

+ Proven experience in formulation development and fill/finish operations for biologics; direct biologics drug product formulation experience is strongly preferred.

+ Hands-on experience with high-throughput formulation development, automated liquid handling systems (e.g., Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent), and robotic…