Senior Scientist, Process Development (AAV)
New York City, NY - USA
Job Summary
RoleSummary
The Senior Scientist supports development optimization and scale-up of AAV manufacturing processes using Sf9/baculovirus and HEK-based systems. This role contributes toearly andlate-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 becommensuratewith 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
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 Friedreichs Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundationLexeois positioned to translate groundbreaking science into durable clinical impact.
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 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 Fr ... View more