Scientist II, Analytical Development

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

Role Summary

This Scientist II will independently design, execute, and analyze research studies and will drive one or more analytical development projects for AAV-based gene therapy programs. The role provides technical leadership in the development, optimization, qualification, validation, and transfer of analytical assays, including cell-based potency and molecular methods such as qPCR andddPCR.The ScientistII will apply broad scientific knowledge and novel approaches to establish AAV mechanisms of action in cellular systems, resolve moderately complex technical issues, and support GMP manufacturing, material release, and regulatory submissions in collaboration with groups across CMC, Quality, QC, and external partners.

The ideal candidate is highly collaborative, detail-oriented, able to manage multiple priorities, and effective in a fast-paced environment.The ScientistII is expected to exercise sound scientific judgment, communicate complex technical issues clearly, build alignment across functions, and serve as a technical resource to colleagues. Thisisa highly visible and impactful role in our CMC organization.

Primary Responsibilities

• Independentlydesign andoptimizeanalytical methods involving in-vitro cell culture and AAV transductiontodemonstratepotency 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

Required Skills and 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
• Experience with pharmaceutical drug-process validation and manufacture a plus
• Knowledge of FDA, cGMP, and ICH guidelines and QBD principles a plus
• 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
• Familiarity with electronic laboratory notebook and inventory systems such as Benchling or Quartzy preferred

$99,680 - $138,500 a year

Compensation is dependent on qualifications and experrience

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 Friedreich's Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation,Lexeois positioned to translate groundbreaking science into durable clinical impact.

LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.