Process Development Senior Scientist - Drug Product Technologies

Amgen seeks a senior scientist to lead early-stage drug product development for antibody-drug conjugates and other biologic modalities. Responsibilities include designing liquid and lyophilized formulations, establishing scalable fill/finish processes, characterizing critical quality attributes, and supporting regulatory submissions. The role requires hands-on ADC formulation experience and cross-functional collaboration in a fast-paced environment.

Responsibilities

• Design and develop liquid and lyophilized formulations; establish scalable fill/finish processes for ADCs and biologics
• Execute formulation and process studies; characterize critical quality attributes to inform product design decisions
• Evaluate stability, in-use compatibility, and investigate ADC-relevant degradation pathways and protein-excipient interactions
• Apply machine learning and high-throughput screening tools for formulation optimization and processability assessment
• Author regulatory documents, risk assessments, and technical packages; support technology transfer with manufacturing partners

Requirements

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field; or Master's degree with 3 years scientific experience; or Bachelor's degree with 5 years scientific experience
• Direct hands-on experience in ADC drug product formulation and process development
• Mechanistic understanding of linker-payload attributes, stability pathways, and ADC analytical characterization
• Proficiency with biophysical techniques (UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, particle analysis)
• Experience developing liquid and lyophilized formulations for biologics with stability testing
• Familiarity with fill/finish operations and clinical-stage manufacturability considerations
• Experience with AI/ML tools and regulatory submission preparation (CTAs, BLAs)