Senior Manager, CMC QC — External Lab Lead (Hybrid)

Lexeo Therapeutics; New York (NY); Hybrid; USD 93,000 - 154,000; Full time

Benefits offered by this job

Hybrid work model

Office in New York City

Job summary

LEXEO Therapeutics in New York is seeking a Manager/Senior Manager, CMC Quality Control to lead external QC activities for release, validation, and stability testing across gene-therapy programs.

The role partners with Analytical Development, Technical Operations, and Regulatory Affairs to ensure analytical methods and specifications support clinical development and future commercial needs.

Qualifications

• Bachelor’s degree in a scientific discipline; MS preferred.
• 8+ years in Quality Control/CMC functions; Sr. Manager criteria.
• Experience with late-stage development, process validation, or commercial readiness.
• Experience with biologics/gene therapy preferred.
• Strong knowledge of cGMP and global regulatory expectations.

Responsibilities

• Lead QC oversight of external contract testing laboratories for 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/Technical Operations for method qualification, validation, transfer, verification and monitoring.
• Act as QC SME for laboratory investigations (OOS/OOT, atypical results, assay failures).
• Coordinate sample submission paperwork and shipments to CTLs; ensure compliance with storage and shipping requirements.
• Collaborate with Regulatory Affairs/CMC to support regulatory submissions and responses.

Job description

LEXEO Therapeutics in New York is seeking a Manager/Senior Manager, CMC Quality Control to lead external QC activities for release, validation, and stability testing across gene-therapy programs.

The role partners with Analytical Development, Technical Operations, and Regulatory Affairs to ensure analytical methods and specifications support clinical development and future commercial needs.