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About the Role
The Manager/Senior Manager, CMC Quality Control (QC) provides strategic and operational oversight of QC activities for Lexeo's gene therapy programs. This role leads QC for external contract testing labs, analytical lifecycle management, stability programs, release testing, and analytical investigations, ensuring analytical methods and testing programs support clinical development and commercial requirements.
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.
Requirements
- 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 + 8 years or MS + 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.
Skills
- Technical expertise in analytical testing
- Oversight of external laboratories
- Driving cross-functional CMC initiatives
- Analytical method lifecycle management
- cGMP regulations
- Analytical techniques for AAV and biologic products (ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, compendial safety testing)
- Analytical control strategy development
- Specification management
Location
- New York City
Work Type
- Hybrid
Experience Level
- Manager/Senior Manager
- 6+ years of experience or 4+ with Master’s
- Sr. Manager level: BS + 8 years or MS + 6 years experience
Education Level
- Bachelor’s degree in a scientific discipline
- Advanced degree (MS) a plus
Salary/Compensations
- $93,000 - $154,000 a year
About the Company
- Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases.
- Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies.
- Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.
Equal Opportunity
- LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.