Process Development Senior Scientist - Drug Product Technologies
Amgen · Thousand Oaks, CA
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Role summary
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.
What they're looking for
- 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)
What you'll be doing
- 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
Privacy & handoff
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