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 and ddPCR. The Scientist II 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 Scientist II is expected to exercise sound scientific judgment, communicate complex technical issues clearly, build alignment across functions, and serve as a technical resource to colleagues. This is a highly visible and impactful role in our CMC organization.
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
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
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.
LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
