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Senior Manager/Associate Director, MSAT/Process Characterization and Validation Readiness (AAV)
Lexeo TherapeuticsGene Therapy company
New York, United StatesSenior
D1 Capital Partners
Omega Funds
Eventide Asset Management
Janus Henderson Investors
Longitude Capital
PBM Capital
About the role
TL;DR
Lead AAV process characterization and validation readiness activities.
- •Lead AAV process characterization, technology transfer, and validation readiness activities.
- •Key Responsibilities Lead risk-based process characterization strategies and studies for AAV manufacturing processes.
- •Evaluate process robustness, critical process parameters, and product quality attributes.
- •Translate development data into technical conclusions that support validation readiness.
- •Requirements Advanced degree in biochemical engineering, bioprocess engineering, molecular biology, cell biology, biotechnology, or related discipline.
- •Experience in viral vector, gene therapy, biologics, or advanced therapy process development.
- •Demonstrated experience with process characterization, process optimization, scale-up, scale-down models, technology transfer, and validation-readiness activities.
Domain expertise
biotech