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.

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,multispecificsandotherbiologicmodalities. 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 liquidandlyophilizedformulations 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 processdesigndecisions.
• 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 gapsimpactingbiologics 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

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these 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

• 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…