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About the Role
This Scientist II role involves independently designing, executing, and analyzing research studies to drive analytical development projects for AAV-based gene therapy programs. The position offers technical leadership in assay development, optimization, qualification, validation, and transfer, including cell-based potency and molecular methods. The role requires applying broad scientific knowledge to establish AAV mechanisms of action, resolve technical issues, and support GMP manufacturing 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
- 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
- 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
- Apply results and learnings from previous studies, and assimilate knowledge or techniques from adjacent scientific fields, to address new or different problems
- Collaborate and build constructive relationships across departments; serve as a technical resource and provide scientific coaching and technical guidance
Requirements
- 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
Skills
- Cell-based potency assays
- Molecular methods (qPCR, ddPCR)
- Tissue culture
- Analytical assay development
- Analytical assay execution
- Data analysis
- Troubleshooting
- Benchling or Quartzy (preferred)
Location
- New York City
Work Type
- Full-time
Experience Level
- Scientist II
Education Level
- BS
- MS
- PhD
Salary/Compensations
- $99,680 - $138,500 a year
About the Company
- Lexeo Therapeutics 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, Lexeo is positioned to translate groundbreaking science into durable clinical impact.
Equal Opportunity
- LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.