Manager/Senior Manager, CMC Quality Control

Role: Senior Manager/Manager, CMC Quality Control, overseeing analytical testing activities supporting gene therapy programs at Lexeo. Responsibilities include managing external labs for release, validation, stability, and comparability testing; supporting lifecycle management of product specifications; leading method qualification, validation, and transfer; and investigating analytical anomalies. The role involves close collaboration with Analytical Development, Regulatory Affairs, and Technical Operations to ensure assays and testing support clinical and commercial readiness, with a focus on biologics, gene therapy, particularly AAV-based products. The position also entails contributing to regulatory submissions and managing sample logistics. Qualifications: Bachelor's in a scientific discipline with 6+ years (or 4+ with MS) in QC, analytical development, or CMC within biotech/pharma; experience with late-stage development or biologics, preferably gene therapies; strong knowledge of cGMP and analytical techniques such as ddPCR, ELISA, and residual impurity testing. Preferred: experience supporting process validation and commercial manufacturing. High-Value: gene therapy/biologics, late-stage development, analytical lifecycle management, biologic techniques, cGMP compliance. Work setup: hybrid NYC; no travel specified.