Process Development Senior Scientist - Drug Product Technologies

Job title: Process Development Senior Scientist - Drug Product Technologies

About the Role

Join Amgen’s Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on ADCs, monoclonal antibodies, multispecifics, and other biologics. This role focuses on designing and developing liquid and lyophilized formulations, evaluating CQAs, and establishing scalable fill/finish processes to support clinical development and regulatory submissions.

What You'll Do

• Design and develop liquid and lyophilized formulations for ADCs, monoclonal antibodies, multispecifics, and other biologic modalities.
• Evaluate critical quality attributes (CQAs) and establish robust, scalable fill/finish processes for complex biologic drug products.
• Author and support high-quality regulatory submissions.
• Bring hands-on experience in ADC drug product formulation and process development, including mechanistic understanding of linker-payload attributes, stability/relevant degradation pathways, and analytical strategies to characterize ADC CQAs.
• Integrate formulation, analytical, and process data to guide product design, apply AI/ML technologies, and collaborate cross-functionally to deliver stable, manufacturable drug products for clinical development in a fast-paced environment.
• Work effectively in a fast-paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams, and communicating technical recommendations to scientific peers and leadership.

What We're Looking For

• Hands-on experience in ADC drug product formulation and drug product process development.
• Mechanistic understanding of linker-payload attributes, stability/process-relevant degradation pathways, and analytical strategies used to characterize ADC CQAs.
• Ability to synthesize formulation, analytical, and process data to guide product design; experience applying cutting-edge technologies including AI/ML; strong cross-functional collaboration.