Senior Scientist, Analytical Development

Gilead Sciences seeks a Senior Scientist for Analytical Development to lead bioassay method development and analytical strategy for biologic therapies in late-stage research and early clinical phases. The role involves designing potency assays, managing comparability studies, and collaborating across research and clinical teams in Foster City, CA.

Responsibilities

• Lead analytical activities for Phase I and II biologic molecules, including comparability studies
• Design, develop, and optimize bioassay potency methods reflecting drug mechanisms of action
• Author method development reports, test procedures, and method transfer documentation
• Oversee data generation and integrity for internal and outsourced testing at contract organizations
• Present scientific findings and provide technical guidance to cross-functional teams and senior staff

Requirements

• Bachelor's degree and 8+ years relevant experience, or Master's with 6+ years, or PhD
• Biologic analytical development experience in biotech or pharmaceutical industry
• Expertise in ELISA, bioassay potency methods, and analytical method validation for biologics
• Experience supporting CMC activities and Phase I IND applications for biologic products
• Hands-on laboratory experience with immunoassays, cell-based assays, and Biacore
• Working knowledge of cGMP requirements and FDA/ICH guidance for biologic products
• Strong collaboration and communication skills with ability to mentor colleagues