Process Development Sr Scientist

Amgen seeks a Process Development Senior Scientist to lead analytical chemistry efforts for biopharmaceutical manufacturing processes. Based in Thousand Oaks, CA, the role combines technical oversight of analytical method development for biologics with cross-functional collaboration and regulatory engagement.

Responsibilities

• Supervise analytical team and provide technical leadership for late-stage product development programs
• Define analytical target profiles and oversee development, qualification, and transfer of analytical methods
• Manage analytical activities at contract manufacturing and testing sites
• Author technical reports and CMC sections for regulatory submissions; respond to regulatory authority questions
• Drive product characterization and comparability studies supporting process development and regulatory filings

Requirements

• PhD, PharmD, or MD; or Master's degree with 3+ years scientific experience; or Bachelor's degree with 5+ years scientific experience
• 5+ years in analytical chemistry, biochemistry, or equivalent discipline
• Experience developing analytical methods for biologic therapeutics including monoclonal antibodies and multispecifics
• Proficiency with mass spectrometry, HPLC, and capillary electrophoresis techniques for biologics
• Knowledge of regulatory requirements and prior experience contributing to or authoring regulatory submissions
• Understanding of GLP and GMP requirements and their application in development phases
• Technical leadership skills with ability to guide multifunctional teams and communicate complex analytical strategies