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
- 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 to author and review regulatory submissions, responses to health authority inquiries, technical reports, and analytical sections of INDs, BLAs, and other global filings
- Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents
- Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements
- Collaborate with cross-functional CMC teams to align on sample submission and testing needs
Required Skills and Qualifications
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology); advanced degree (MS) a plus
- 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
- Experience supporting late-stage development, process validation, and/or commercial readiness activities preferred
- Experience supporting biologics, cell therapy, gene therapy, or other advanced therapeutics preferred
- Strong understanding of cGMP regulations and global regulatory expectations applicable to analytical testing and Quality Control
- Experience with analytical method lifecycle management, including qualification, validation, transfer, verification, and continued performance monitoring
- Knowledge of analytical techniques commonly used for AAV and biologic products (i.e., ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, compendial safety testing)
- Strong understanding of analytical control strategy development and specification management
About LEXEO
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.
Skills Required
- Bachelor's degree in Chemistry, Biology, Biotechnology, or another scientific discipline
- 6 or more years of experience with a bachelor's degree, or 4 or more years with a master's degree, in Quality Control, Analytical Development, Manufacturing Sciences, Quality Assurance, or related CMC functions
- For Senior Manager level, 8 or more years with a bachelor's degree or 6 or more years with a master's degree
- Experience supporting late-stage development, process validation, or commercial readiness activities
- Experience supporting biologics, cell therapy, gene therapy, or other advanced therapeutics
- Strong understanding of cGMP regulations and global regulatory expectations for analytical testing and Quality Control
- Experience with analytical method lifecycle management, including qualification, validation, transfer, verification, and continued performance monitoring
- Knowledge of analytical techniques used for AAV and biologic products, including ddPCR, cell-based potency, ELISA or immunoassays, residual impurities, and compendial safety testing
- Strong understanding of analytical control strategy development and specification management
- Advanced degree such as a master's degree
What We Do
LEXEO Therapeutics is a New York City-based, clinical-stage gene therapy company focused on addressing some of the most devastating genetically defined cardiovascular and central nervous system diseases affecting both larger-rare and prevalent patient populations. LEXEO’s foundational science stems from partnerships and exclusive licenses with leading academic laboratories at Weill Cornell Medical College and the University of California, San Diego, two preeminent institutions on the cutting edge of gene therapy research. LEXEO is advancing a deep and diverse pipeline of AAV-based gene therapy candidates in rare cardiovascular diseases, APOE4-associated Alzheimer’s disease, and CLN2 Batten disease, and is led by pioneers and experts with decades of collective experience in genetic medicines, rare disease drug development, manufacturing and commercialization. For more information, please visit www.lexeotx.com.
