Biotechnology

Manager/Senior Manager, CMC Quality Control

New York, NYHybridFull TimeManager / HeadPosted 1 month agoVisa sponsorship available

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Required skills

CMC
Quality Control
gene therapy
AAV
cGMP
analytical methods
specifications
release testing
validation
stability testing

Nice to have

late-stage development
process validation
commercial readiness
biologics
cell therapy
advanced therapeutics

Role summary

Lexeo is seeking a Manager/Senior Manager, CMC Quality Control to provide strategic and operational oversight for gene therapy programs. This role involves leading QC activities with external contract testing labs, managing analytical lifecycles, stability programs, and release testing. The individual will collaborate with cross-functional teams and external partners to ensure analytical methods and specifications meet clinical development and commercial requirements. Expertise in analytical testing, AAV-based products, and overseeing external labs is essential.

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.

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Manager/Senior Manager, CMC Quality Control

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