Senior Drug Product Scientist & SKU Lead

BioSpace; Thousand Oaks (CA); In loco; USD 140.000 - 190.000; Tempo pieno

Descrizione del lavoro

Amgen, a leader in biopharmaceuticals, seeks a Scientist/Senior Engineer, Drug Product to provide technical and project leadership for drug product formulation, fill/finish, inspection, and lifecycle management. You will work across global teams to ensure robust commercialization, lifecycle management, and reliable supply of SKUs.

The role involves collaboration with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain, with domestic and international travel as needed.

Competenze

• PhD in a relevant technical field.
• MS with 4+ years in operations, process development, scientific, or engineering fields.
• BS with 6+ years in operations, process development, scientific, or engineering fields.

Mansioni

• Lead Drug Product SKU for formulation, fill/finish, presentation, and lifecycle management.
• Lead or support technology transfers including process characterization and on-site support.
• Provide technical leadership for parenteral drug product unit operations.
• Plan, design, and execute lab, offline, and on-site studies related to drug product process development.
• Support cross-functional teams to ensure product quality and supply continuity.
• Prepare technical protocols, study reports, process transfer documents, and regulatory submissions.

Conoscenze

Cross-functional collaboration

Technical leadership

Data analysis

Statistical methods

Communication

Formazione

Doctorate degree

Master's degree with 4 years experience

Bachelor's degree with 6 years experience

Strumenti

Statistical software

AI-enabled tools

Descrizione del lavoro

Amgen, a leader in biopharmaceuticals, seeks a Scientist/Senior Engineer, Drug Product to provide technical and project leadership for drug product formulation, fill/finish, inspection, and lifecycle management. You will work across global teams to ensure robust commercialization, lifecycle management, and reliable supply of SKUs.

The role involves collaboration with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain, with domestic and international travel as needed.