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Lexeo Therapeutics
New York, New York
Source: Lexeo Therapeutics careers · View original posting
From Lexeo Therapeutics's posting. “We” and “our” refer to the employer.
Role Summary
The Manager/Senior Manager, CMC Quality Control (QC) is responsible for providing strategic and operational oversight of QC activities supporting Lexeo's gene therapy programs. This role serves as a QC lead for external contract testing laboratories (CTLs), analytical lifecycle management (i.e., late-phase method validation), stability programs, release testing support, and analytical investigation activities.
The individual will work closely with Analytical Development, Technical Operations, Regulatory Affairs, Quality Assurance, and external partners to ensure analytical methods, specifications, and testing programs support clinical development, process validation readiness, and future commercial requirements.
This position requires technical expertise in analytical testing, preferably of AAV-based products, as well as demonstrated experience overseeing external laboratories and driving cross-functional CMC initiatives.
Primary Responsibilities: Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing activities
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 across testing laboratories
Collaborate with Regulatory Affairs and CMC teams to author and review regulatory submissions, responses to health authority inquiries, technical reports, and analytical sections of INDs, BLAs, and other global filings
6+ years of experience or 4+ with Master’s (Sr. Manager level: BS with 8+ years or MS with 6+ years experience) in Quality Control, Analytical Development, Manufacturing Sciences, Quality Assurance, or related CMC functions within biotechnology or pharmaceutical organizations
Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach.
The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need.
Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
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