Manager/Senior Manager, CMC Quality Control

Lexeo Therapeutics · New York, NY

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Role summary

Lexeo Therapeutics seeks a Manager/Senior Manager of CMC Quality Control to oversee quality control operations for gene therapy programs. The role involves managing contract testing laboratories, analytical method validation, stability programs, and investigations while collaborating with cross-functional teams on regulatory and commercial readiness.

What they're looking for

Technical expertise in analytical testing, preferably with AAV-based gene therapy products
Demonstrated experience overseeing and managing external contract testing laboratories
Knowledge of analytical lifecycle management and late-phase method validation
Experience with stability programs and release testing protocols
Ability to drive cross-functional CMC initiatives and regulatory strategies

What you'll be doing

Provide strategic and operational oversight of quality control activities for gene therapy programs
Lead external contract testing laboratories and manage analytical investigation activities
Oversee analytical method validation, specifications development, and testing program lifecycle
Collaborate with Analytical Development, Technical Operations, and Regulatory Affairs on process validation readiness
Support clinical development and ensure analytical systems meet future commercial requirements

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