Description

You will drive the CMC strategy for next-generation biologics and ADCs, bridging AI-driven discovery with clinical manufacturing. Responsibilities include overseeing end-to-end technical development, optimizing conjugation chemistries, managing global CDMOs, and authoring regulatory filings.

Requirements

• PhD or MSc in Biochemistry, Chemical Engineering, or related field
• 8+ years (or 5+ for high-growth) experience in biologics CMC
• Track record of moving complex modalities from discovery to clinical manufacturing
• Experience with diverse next-generation modalities (multi-specifics, ADCs)

Responsibilities

• Design and oversee end-to-end manufacturing for novel scaffolds and functionalized antibodies
• Lead optimization of site-specific modification and coupling chemistries
• Select and oversee global CDMOs; manage tech transfers and troubleshoot deviations
• Define Analytical Target Profile for complex molecules
• Author CMC sections for global regulatory filings