About this role
Job title: Process Development Principal Scientist
About the Role Join Amgen’s Attribute Sciences within the Process Development organization to define favorable quality characteristics of therapies and optimize analytical tools to guide development. You will lead analytical efforts across a broad range of manufacturing processes, including synthetic medicines, and work cross-functionally with Drug Substance, Drug Product, and Product Quality to deliver robust processes for commercial use.
What You'll Do
- Provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid molecules, and collaborate with Drug Substance, Drug Product, and Product Quality.
- Lead all attribute and analytical aspects of programs in pivotal clinical process development, while working cross-functionally within Product Development teams.
- Define analytical control strategies and implement methodologies for late-phase clinical programs, including analytical method development and optimization.
- Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites.
- Author technical reports and CMC sections in regulatory documents; respond to analytical and product quality questions from health authorities.
- Drive product characterization.
What We're Looking For
- Experience leading Attribute Sciences within Process Development and providing strategic analytical leadership for commercial manufacturing processes for synthetic and hybrid molecules.
- Strong collaboration across Drug Substance, Drug Product, and Product Quality.
- Ability to define analytical control strategies, develop/optimize analytical methods, and lead method transfer; experience with cGMP manufacturing.
- Experience with regulatory submissions (CMC) and responding to health authorities questions.
- Experience with synthetic and hybrid molecules (including oligonucleotides and small molecules) and broad therapeutic modalities.
- Excellent cross-functional communication and leadership skills.