Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies

Career Category Operations 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. 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 Sr 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.  Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.  Plan and execute formulation 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.  Build process understanding across unit operations to support scalable drug product development.  Evaluate in-use compatibility and drug product stability under clinical conditions.  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. Partner with automation engineers, data scientists, and digital teams to deploy integrated automated workflows that support formulation development, stability studies, and process characterization. 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 advanced data science to predictive modeling, workflow acceleration, and decision-making.  Ensure development approaches are phase-appropriate, from discovery through clinical manufacturing.  Author technical documents, control-strategy inputs, risk assessments, IND/CTA regulatory sections,