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Role Summary The Senior Scientist 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 development and optimization studies for AAV manufacturing using Sf9 cells/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.
Master’s 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.
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