Manager/Senior Manager, CMC Quality Control

Lexeo Therapeutics

. Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing .

Posted 9/17/2026full-timeNew York City • New York • United StatesSenior💰 $93,000 - $154,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Control oversight, analytical method lifecycle management, and regulatory compliance within biotechnology and pharmaceutical sectors. Proficient in collaborating with cross-functional teams to ensure successful product development and regulatory submissions.

Highest-signal resume keywords

Quality Control OversightAnalytical Method Lifecycle ManagementCGMP RegulationsRegulatory SubmissionsAnalytical Techniques for Biologics

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Method QualificationMethod ValidationMethod TransferPerformance MonitoringAssay Failure InvestigationAnalytical ComparabilitySpecification ManagementSample Submission ManagementAnalytical Control Strategy DevelopmentRegulatory Impact Assessment

Industry Keywords

BiotechnologyPharmaceuticalQuality AssuranceManufacturing SciencesCell TherapyGene TherapyAAV ProductsINDsBLAsCGMP Compliance

About the role

Key responsibilities & impact

Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing
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
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 on regulatory submissions, health authority responses, technical reports, and analytical sections of INDs, BLAs, and other global filings
Prepare and manage sample submission paperwork for external contract testing laboratories, including quotes, purchase orders, and shipping documents
Coordinate shipment of samples, reference standards, and reagents in compliance with storage and shipping requirements
Collaborate with cross-functional CMC teams to align sample submission and testing needs

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology)
6+ years of experience, or 4+ years with a Master’s; Sr. Manager level: BS + 8 years or MS + 6 years experience
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, including ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, and compendial safety testing
Strong understanding of analytical control strategy development and specification management

Benefits

Comp & perks

Hybrid work model: 2 days/week in the New York City office and 3 days working from home
EEO employer committed to a diverse and enriching work environment