ManagerSenior Manager, CMC Quality Control
Job Location:
New York City, NY - USA
Yearly Salary:
Posted:
Application Deadline:
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Job Summary
Role Summary
The Manager/Senior Manager CMC Quality Control (QC) is responsible for providing strategic and operational oversight of QC activities supporting Lexeos 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.
- 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
- Bachelors degree in a scientific discipline (e.g. Chemistry Biology Biotechnology); advanced degree (MS) a plus
- 6 years of experience or 4 with Masters (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
LexeoTherapeutics 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 Friedreichs Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundationLexeois positioned to translate groundbreaking science into durable clinical impact.
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.
Required Experience:
Senior Manager
About Company
About Lexeo 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 Fr ... View more
