Process Development Senior Scientist – Late-Stage Drug Product Development

Overview

Join Amgen’s mission of serving patients by working on late-stage drug product formulation and process development for biologics modalities such as monoclonal antibodies, BiTEs, and fusion proteins.

Key Responsibilities

• Design, plan, and execute formulation and fill/finish process studies.
• Develop technical project plans and comprehensive data packages.
• Author and review protocols, reports, and regulatory documents.
• Perform data analysis using statistical techniques and software.
• Collaborate with management, cross-functional partners, and stakeholders.

Qualifications

Basic degrees with requisite scientific experience are required. Advanced degrees in Chemical Engineering, Biomedical Engineering, Biochemistry or related fields are preferred with post-doctoral or industry exposure in pharmaceuticals. Experience includes formulation development, process characterization, scale-up, and data visualization.

What You Can Expect

Amgen offers competitive benefits, a collaborative culture, opportunities for career development, and flexible work models including remote and hybrid arrangements.

Key skills/competency

• Process Development
• Formulation
• Biologics
• Process Characterization
• Data Analysis
• Regulatory Documents
• Statistical Analysis
• Project Management
• Scale-up
• Cross-functional Collaboration