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.
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 3-6 years of relevant experience, or PhD with 2-4 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.
$151,400 - $157,000 a year
Compensation is dependent on qualifications and experience
Our work culture is a hybrid model with 2 days in the New York City office and 3 days working from home.
