Process Development Senior Principal Scientist

Role: Process Development Senior Principal Scientist specializing in biologics, particularly ADCs, supporting drug product formulation, process development, and tech transfer for late-stage biologics at Amgen. Objectives include leading formulation design, stability, and fill/finish process development; integrating analytical, formulation, and process data; and applying advanced technologies like AI/ML for predictive modeling. Responsibilities encompass planning and executing laboratory studies, authoring regulatory documents, managing technology transfer activities, and leading cross-functional teams to ensure successful commercialization and lifecycle management. Qualifications: PhD/PharmD/MD with 2+ years of scientific experience or equivalent with relevant industry experience; advanced degree in engineering, pharmaceutics, or biotech preferred. Requires 8+ years in pharma/biotech, with expertise in biologics, ADC drug product development, stability testing, and regulatory strategy. Technical skills needed include proficiency in analytical biophysical techniques, statistical software, programming (e.g., Python, R), and data visualization tools. High-value specifics involve ADC drug development, formulation, stability, and regulatory engagement. Work setup involves onsite or hybrid in Thousand Oaks, CA, with travel up to 10%. The role demands leadership in matrixed teams, strong cross-functional collaboration, and a focus on innovative biologics manufacturing.