Process Development Senior Scientist - Drug Product Technologies

Amgen seeks a Process Development Senior Scientist to lead early-stage drug product development for antibody-drug conjugates and other biologics. The role encompasses formulation design, stability assessment, fill/finish process development, and regulatory support within a cross-functional, fast-paced environment.

Responsibilities

• Plan and execute formulation and fill/finish process studies for early-stage ADC and biologic programs
• Develop and characterize liquid and lyophilized formulations while evaluating critical quality attributes and stability pathways
• Build process understanding across unit operations to support scalable drug product development and manufacturability
• Author technical documents, regulatory submissions, control-strategy inputs, and technology transfer packages
• Collaborate cross-functionally with process development, research, regulatory, and manufacturing teams to advance programs and support CMO/CDMO technology transfer

Requirements

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field; or Master's degree with 2 years scientific experience; or Bachelor's degree with 4 years scientific experience
• Direct experience in ADC drug product formulation and process development with mechanistic understanding of linker-payload attributes
• Hands-on expertise in liquid and lyophilized formulation development for biologics and fill/finish operations
• Demonstrated proficiency in analytical techniques: UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis
• Experience integrating formulation, stability, and analytical data to advance candidates from discovery into clinical manufacturing
• Familiarity with regulatory submissions, clinical-stage development, and risk-based decision-making
• Experience applying AI/ML tools to R&D optimization and workflow acceleration