Senior Principal Scientist, ADC Drug Product & Process

BioSpace; Thousand Oaks (CA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Amgen in Thousand Oaks, CA is seeking a Process Development Senior Principal Scientist to lead drug product design and formulation development within the Pivotal Drug Product Technologies group. You will drive technology transfer, oversee cross-functional teams, and apply AI/ML to optimize formulation and process strategies.

The role emphasizes collaboration with CMOs/CDMOs, regulatory interactions, and delivering scalable, manufacturable biologics for late-stage programs.

Qualifikationen

• PhD/MD/PharmD with 2+ years of scientific experience or MSc with 5+ years of experience.
• Experience in ADC drug product formulation and process development.
• Ability to travel up to 10% of time.

Aufgaben

• Lead planning, design, execution, and documentation of laboratory studies related to drug product design, formulation, and process development, and tech transfer.
• Deliver progress reports and presentations to inform management of status and needs.
• Author and review guidelines, protocols, reports, and regulatory responses.
• Develop and characterize liquid and lyophilized formulations for biologics, focusing on ADC drug product formulation and handling.
• Lead technology transfer activities, including CMOs/CDMOs collaborations and troubleshooting during campaigns.
• Apply machine learning, AI, and data science to predictive modeling and decision making.
• Serve as a Drug Product Team Lead to develop strategy for commercialization and lifecycle management.

Kenntnisse

Leadership

Drug product formulation

AI/ML data science

Cross-functional collaboration

Ausbildung

PhD/MD/PharmD with 2+ years

Masters with 5+ years

Bachelors with 7+ years

Jobbeschreibung

Amgen in Thousand Oaks, CA is seeking a Process Development Senior Principal Scientist to lead drug product design and formulation development within the Pivotal Drug Product Technologies group. You will drive technology transfer, oversee cross-functional teams, and apply AI/ML to optimize formulation and process strategies.

The role emphasizes collaboration with CMOs/CDMOs, regulatory interactions, and delivering scalable, manufacturable biologics for late-stage programs.