Scientist II, Analytical Development
Job Location:
New York City, NY - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 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 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.
- 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
- Collaborateand 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
About LEXEO
Lexeo Therapeutics is a New York City-based clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease including LX2006 for Friedreich ataxia (FA) LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy and others in devastating diseases with high unmet need.
LEXEO Therapeutics is an EEO employer committed to an exciting diverse and enriching work environment.
Required Experience:
IC
About Company
About LEXEO Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the pat ... View more
