Senior Manager, Biologics Development

Job Summary

To support the development and lifecycle management of bioassays for biologics programs, the full-time Senior Manager, Biologics Analytical Development (Bioassay) will execute and oversee the development, qualification, and validation of assays, ensuring compliance with regulatory standards in a remote environment.

Key Responsibilities

• Execute and support development, optimization, qualification, and validation of cell-based and ligand-binding bioassays
• Provide scientific oversight and serve as a subject matter expert on cross-functional project teams, contributing to regulatory submissions
• Ensure high-quality delivery of analytical documents and manage method transfers to internal and external laboratories

Required Qualifications

• PhD in Biology, Biochemistry, Immunology, Bioengineering, or a related discipline
• 8-10+ years of experience in analytical development for biologics, with a strong emphasis on bioassay development
• Demonstrated leadership experience managing scientific teams
• Strong hands-on and theoretical knowledge of cell-based and ligand-binding assays
• Solid understanding of ICH, USP, FDA, and EMA expectations for bioassays