Process Development Senior Scientist

Responsibilities

• Lead late-stage drug product formulation and process development for biologics modalities including monoclonal antibodies, bispecific T-cell engagers, and fusion proteins
• Design, plan, and document formulation and process development studies
• Apply scientific and engineering principles to develop, characterize, and implement next-generation technologies
• Use advanced statistical and data analytics techniques to inform technical decisions
• Support clinical and commercial fill/finish manufacturing through troubleshooting, root cause analysis, and process capability analysis
• Author and review technical protocols, reports, and regulatory sections for IND and marketing application submissions
• Lead cross-functional initiatives to enhance Pivotal Drug Product platforms

Requirements

• Doctorate degree OR Master’s degree with 3 years of scientific experience OR Bachelor’s degree with 5 years of scientific experience
• Experience in pharmaceutical or biotechnology development
• Expertise in biologics process development and formulation
• Experience with drug product manufacturing and formulation characterization
• Proficiency in statistical software such as SAS, JMP, or Minitab

Preferred Qualifications

• Advanced Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or Pharmaceutics
• Experience in fill-finish process engineering and technical transfers to global manufacturing sites
• Experience with unit operation scale-down model development (e.g., filling, filtration, mixing)
• Understanding of protein physical/chemical stability and process-related stress impacts
• Strong project management and problem-solving skills

Benefits

• Comprehensive medical, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program and stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, Amgen has pioneered biologics to treat cancer, inflammatory conditions, rare diseases, and cardiovascular issues, leveraging advanced human genetics to deliver innovative medicines worldwide.