Senior Scientist I, Process Development (AAV)
Job Location:
New York City, NY - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
RoleSummary
The Senior Scientist I supports development optimization and scale-up of AAV manufacturing processes using Sf9/baculovirus and HEK-based systems. This role contributes to early and late-stage CMC activities including process characterization technology transfer control strategy development and regulatory documentation. The level of responsibility technical leadership and cross-functional ownership will be commensurate with experience.
- Design execute and lead process developmentandoptimizationstudies for AAV manufacturing using Sf9cells/baculovirus and HEK platforms.
- Perform hands-on laboratory work to execute process development and optimization experiments generate critical process data and support technical troubleshooting.
- Support and as appropriate define study designs to drive process optimization scalability robustness and technology transfer for clinical and late-stage programs.
- Collaborate with and provide technical leadership across upstream downstream analytical manufacturing and quality teams to evaluate process performance and product quality.
- Support or own late-stage CMC deliverables including process characterization risk assessments control strategy development technology transfer and validation readiness.
- Author review and provide technical input for study protocols technical reports and regulatory documentation.
- Support or lead troubleshooting investigations mentoring of junior staff and continuous process improvement initiatives.
- Masters degree in biochemical engineering bioprocess engineering molecular biology cell biology or relevant life sciences or engineering discipline with a minimum of 6 years of relevant experience or PhD with at least 3 years of relevant experience.
- Hands-on experience with upstream AAV production using Sf9 cells/baculovirus and HEK platforms required.
- Understanding of virus/viral vector properties and experience with development of upstream and downstream processes for viral vectors or gene therapy products are highly desirable.
- Working knowledge of downstream processing and analytical testing preferred.
- Experience supporting process optimization characterization and late-stage CMC activities preferred.
- Demonstrated leadership in process development cross-functional collaboration and late-stage CMC readiness is expected.
- Experience authoring and reviewing regulatory documentation 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.
Our work culture is a hybrid model with 2 days in the New York City office and 3 days working from home.
LEXEO Therapeutics is an EEO employer committed to an exciting diverse and enriching work environment.
Required Experience:
Senior 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
