Manager/Senior Manager, CMC Quality Control

Lexeo Therapeutics, Inc.; New York (NY); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Lexeo Therapeutics, Inc. is seeking a Manager/Senior Manager, CMC Quality Control to provide strategic and operational oversight of QC activities supporting gene therapy programs.

The role leads external contract testing laboratories, manages late-phase method validation, stability programs, and release testing, while driving analytical investigations. You will collaborate with Analytical Development, Technical Operations, Regulatory Affairs, and QA to align analytical methods with clinical

Qualifications

• BS in Chemistry, Biology, or Biotechnology required; MS preferred.
• 6+ years in QC/CMC within biotech/pharma.
• Experience with late-stage development and process validation.
• Biologics, cell therapy, or gene therapy experience 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.
• 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 ongoing monitoring.
• Serve as QC SME for investigations (OOS/OOT/assay failures).
• Coordinate reference standard qualification and analytical comparability initiatives.
• Oversee transfers, comparability assessments, and laboratory readiness.
• Collaborate with Regulatory Affairs/CMC to draft regulatory submissions and technical reports.
• Prepare/manage sample submission paperwork for CTLs; coordinate shipments and storage.

Skills

Quality Control

Analytical Development

Manufacturing Sciences

Quality Assurance

cGMP

Biotechnology

Pharmaceuticals

GMP

external labs oversight

Education

Bachelor’s degree in a scientific discipline

MS degree preferred

Tools

ddPCR

ELISA

Immunoassays

Cell-based potency

Assay transfer/verification

Job description

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.