Process Development Senior Scientist

Amgen seeks a Process Development Senior Scientist to join the Pivotal Drug Product Technologies group in Thousand Oaks, California. The role involves formulation and process development for late-stage biologics, including enzymes, monoclonal antibodies, and peptides, with emphasis on stability characterization, analytical strategies, and integration of AI/machine learning approaches.

Responsibilities

• Participate in drug product commercialization teams conducting process development for pipeline and commercial products
• Design, plan, and document formulation and process development studies with rigorous scientific methodology
• Develop and characterize liquid formulations for biologics with emphasis on enzyme and co-formulation approaches
• Apply machine learning and advanced statistical analytics to predictive modeling and decision-making
• Author and review technical protocols, risk assessments, and regulatory submissions for IND and marketing applications

Requirements

• PhD, PharmD, or MD; or Master's degree with 3+ years scientific experience; or Bachelor's degree with 5+ years scientific experience
• Hands-on experience in biologics drug product formulation and co-formulation across multiple modalities
• Strong understanding of protein stability, degradation pathways, and critical quality attribute characterization
• Experience with analytical and biophysical techniques (UPLC/HPLC, SEC, IEX, CE-SDS, particle analysis)
• Demonstrated ability to integrate formulation, analytical, and process data to guide product design
• Experience with fill-finish process engineering, technical transfer, and statistical process control
• Proficiency in programming, AI-enabled tools, and data visualization (Tableau, Spotfire)