Lexeo Therapeutics

Manager

• Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing
• Support product specification lifecycle management, including establishment, justification, trending, revision, and regulatory impact assessment
• Partner with Analytical Development and Technical Operations to support method qualification, validation, transfer, verification, and continued performance monitoring
• Serve as QC subject matter expert for laboratory investigations, including OOS, OOT, atypical results, assay failures, and method performance events
• Support reference standard qualification, lifecycle management, and analytical comparability initiatives
• Provide technical oversight for method transfers, comparability assessments, and laboratory readiness
• Collaborate with Regulatory Affairs and CMC teams on regulatory submissions, health authority responses, technical reports, and analytical sections of INDs, BLAs, and other global filings
• Prepare and manage sample submission paperwork for external contract testing laboratories, including quotes, purchase orders, and shipping documents
• Coordinate shipment of samples, reference standards, and reagents in compliance with storage and shipping requirements
• Collaborate with cross-functional CMC teams to align sample submission and testing needs

Manager/Senior Manager, CMC Quality Control