About this role
About the Role Join Amgen’s Integrated Pharmaceutical Attribute Sciences (iPAS) team in Thousand Oaks, CA, focusing on late-phase analytical development including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products. The role provides analytical expertise to understand key quality attributes in products and processes for late-phase synthetic small molecules, synthetic peptides, and/or siRNA programs, enabling progression to clinical and regulatory milestones. What You'll Do
- Define analytical control strategies and implement methodologies to support late-phase clinical programs, with the ability to articulate challenges and complexities of analytical control strategy development.
- Develop, optimize, and authorize analytical methods for synthetic small molecules, synthetic peptide, and/or siRNA release testing and characterization.
- Collaborate closely with drug substance and drug product process development teams to achieve project objectives.
- Provide analytical data to support drug substance and drug product development, including purity analysis. What We're Looking For
- Experience in analytical development for late-phase clinical programs.
- Strong knowledge of analytical method development, validation, transfer, and GMP testing.
- Ability to define analytical control strategies and to communicate complex analytical challenges.
- Experience with synthetic small molecules, synthetic peptides, and/or siRNA programs is a plus.
- Collaborative mindset and ability to work with cross-functional teams.