Process Development Senior Scientist
Amgen · Thousand Oaks, CA
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Role summary
This role focuses on developing formulations and manufacturing processes for oral solid dosage forms targeting complex small molecules, including protein degraders and molecular glues. The senior scientist will lead drug product strategy across early-stage synthetic molecule programs, design scalable formulations for clinical use, and collaborate with internal and external manufacturing partners to advance Amgen's oncology and therapeutic pipeline.
What they're looking for
- PhD in Pharmaceutical Sciences, Bioengineering, Chemical Engineering, or related discipline
- Experience with enabling formulation technologies including hot melt extrusion and spray dried dispersions
- Hands-on oral solid dosage form process development and scale-up experience
- Understanding of formulation strategies for poorly soluble compounds and bioavailability enhancement
- Experience authoring regulatory documentation such as INDs and CTAs
- Strong cross-functional project management and communication abilities
What you'll be doing
- Lead drug product strategy and execution for early-stage synthetic molecule programs independently
- Design and execute formulation and process development studies for oral solid dosage forms
- Serve as primary drug product representative on cross-functional synthetic molecule development teams
- Partner with internal and external manufacturing partners on scale-up, technology transfer, and GMP manufacturing
- Identify technical risks, develop mitigation strategies, and author regulatory submissions
Privacy & handoff
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