Analytical Scientist II, AAV Gene Therapy

Lexeo Therapeutics; New York (NY); On-site; USD 100,000 - 139,000; Full time

Job summary

Lexeo Therapeutics, a clinical-stage gene therapy company headquartered in New York City, seeks a Scientist II to design, execute, and analyze analytical development studies for AAV programs. You will lead assay development and contribute to GMP material release and regulatory submissions with cross-functional teams.

The role requires strong cell culture, analytical methods, and data interpretation skills, with collaboration across CMC, Quality, QC, and external partners.

Qualifications

• BS in Biology or related field with 6–8 years of experience (MS with 4–6 years or PhD with 1–3 years)
• Experience in cell and gene therapy products
• Hands-on tissue culture, analytical assay development and troubleshooting
• Familiarity with FDA, cGMP, and ICH guidelines is a plus

Responsibilities

• Independently design and optimize analytical methods involving in vitro cell culture and AAV transduction to demonstrate potency of vectors
• Assist in development and testing of CQAs and potency assays
• Generate high-quality data to support qualification, validation, and QC activities for GMP material release
• Analyze and communicate findings through reports and presentations
• Support analytical strategy and regulatory submissions with CMC, Quality, and CROs
• Identify technical risks and develop mitigation strategies for assay performance
• Collaborate on documentation and protocols for late-phase validation at CDMO/CROs
• Maintain accurate lab records and ensure regulatory compliance
• Apply industry best practices and QA standards for analytical development
• Learn from related fields to address new problems and achieve project goals
• Collaborate and provide technical guidance within project teams

Skills

Cell culture

Analytical assay development

qPCR

ddPCR

GMP knowledge

Regulatory submissions support

Education

BS in Biology or related field

MS in related field

PhD in related field

Tools

Benchling

Quartzy

Electronic Laboratory Notebook

Job description

Lexeo Therapeutics, a clinical-stage gene therapy company headquartered in New York City, seeks a Scientist II to design, execute, and analyze analytical development studies for AAV programs. You will lead assay development and contribute to GMP material release and regulatory submissions with cross-functional teams.

The role requires strong cell culture, analytical methods, and data interpretation skills, with collaboration across CMC, Quality, QC, and external partners.