Senior Scientist I, Process Development (AAV)

Role Summary

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.

Primary Responsibilities

• 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.

Required Skills and Qualifications

• 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.