ImmuneBridge

Director

• Own CMC for the lead trispecific T-cell engager program from discovery handoff through IND
• Build and manage the integrated CMC plan from development candidate nomination to first-in-human
• Run a competitive CDMO selection RFP across US, European, and Chinese CDMOs
• Negotiate and manage the selected CDMO across cell line, process, analytical, technology transfer, GMP manufacturing, and stability activities
• Own outsourced manufacturing quality, including quality agreements, batch records, deviations, OOS handling, specifications, and GMP material release/disposition
• Own the CMC budget and forecast against the cash plan
• Own analytical and release strategy, including the cell-based potency assay
• Secure GLP toxicology material and manage clinical supply, labeling, packaging, comparator sourcing, and shipment to trial sites
• Author and QC Module 3 and build CMC content for the pre-IND briefing package
• Participate in agency meetings
• Identify format-driven CMC risks involving chain pairing, product-related species, and purification strategy
• Report on an interim basis to the Head of Research pending hire of the Chief Scientific Officer

Explore CMC Asset Lead – Director Level, Consulting at ImmuneBridge. Review requirements and application details.