Scientist II, Analytical Development

Lexeo Therapeutics is hiring a Scientist II, Analytical Development to drive analytical development projects for AAV-based gene therapy programs. The role develops, optimizes, qualifies, validates, and transfers analytical assays and supports GMP manufacturing, material release, and regulatory submissions.

Responsibilities

• Independently design and optimize analytical methods involving in-vitro cell culture and AAV transduction to demonstrate potency of the gene therapy vectors
• Assist in the timely development and internal testing of CQAs, including potency assays, in a target-specific manner
• Generate high-quality, reproducible data to support assay qualification, validation, method transfer, and QC-related activities for GMP material release
• Analyze, interpret, summarize, and communicate findings through technical reports and presentations that clearly describe the scientific problem, relevant literature, experimental procedures, observations, and conclusions
• Assist in driving analytical strategy and support regulatory submissions in collaboration with internal groups across CMC, Quality, and CROs
• Identify technical risks related to assay performance, evaluate relevant factors, and develop mitigation strategies, novel processes, or alternative approaches to solve problems and support continuous improvement
• Collaborate on and review technical documentation and protocols to support late-phase assay validation projects at respective CDMO/CROs
• Maintain accurate laboratory records and ensure compliance with company policies and regulatory standards
• Apply industry best practices, regulatory expectations, and quality standards related to analytical development for gene therapy products, exercising judgment within generally defined practices and policies when selecting methods and techniques
• Apply results and learnings from previous studies, and assimilate knowledge or techniques from adjacent scientific fields, to address new or different problems and achieve project goals
• Collaborate and build constructive relationships across departments; serve as a technical resource and provide scientific coaching and technical guidance within project teams

Preferred

• Experience with pharmaceutical drug-process validation and manufacture a plus
• Knowledge of FDA, cGMP, and ICH guidelines and QBD principles a plus
• Familiarity with electronic laboratory notebook and inventory systems such as Benchling or Quartzy preferred
• Pharmaceutical Process Validation
• Pharmaceutical Manufacturing
• FDA Guidelines
• cGMP
• ICH Guidelines
• QbD Principles
• Electronic Lab Notebooks
• Inventory Systems
• Benchling
• Quartzy

Company

• Clinical-stage genetic medicines for cardiovascular and APOE4-associated Alzheimer's disease
• New York, New York, USA
• https://www.lexeotx.com/
• Founded in 2018
• 51-200 employees

Qualifications

• BS in Biology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 6-8 years of relevant experience (MS with 4-6 years or PhD with 1-3 years of relevant industry experience)
• Experience in cell and gene therapy products
• Strong hands-on experience with tissue culture, analytical assay development and execution, data analysis, and troubleshooting
• Strong organizational skills, attention to detail, and data accuracy
• Excellent communication, collaboration, and problem-solving skills with the ability to work effectively across functional teams
• Cross functional acumen and highly skilled in working with complex issues and creating direction in shifting priorities and ambiguity. Results oriented with breadth and depth in pharmaceutical development and commercial products to resolve complex problems
• Results-oriented, with strong initiative, accountability, and willingness to take ownership of projects, deliver milestones, and drive work to completion
• Experience with pharmaceutical drug-process validation and manufacture a plus
• Knowledge of FDA, cGMP, and ICH guidelines and QBD principles a plus
• Familiarity with electronic laboratory notebook and inventory systems such as Benchling or Quartzy preferred

Required skills

• Analytical Assay Development, Analytical Assay Execution, Benchling, CGMP, Cell and Gene Therapy, ICH Guidelines, Pharmaceutical Manufacturing, Pharmaceutical Process Validation, Quality by Design (QbD), Quartzy, Tissue Culture

Preferred skills

• $554M, (1), (2), *2026, 2021, 2022, 2024, 2025-05-27, 2025-06-24, 2025-10-16, 40, Balyasny Asset Management, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Engineering and Development, Frazier Life Sciences,Janus Henderson Investors, H1B Sponsorship, Key Investors, Leadership Team, Management and Executive, New York, New York, USA, Perceptive Xontogeny Venture Fund,venBio Partners, Post Ipo Equity· $154M, Post Ipo Equity· $40M, Post Ipo Equity· $80M, Public Company, Represents job field similar to this job, Total Funding, Trends of Total Sponsorships, https://www.lexeotx.com

Experience

• 6-8 years