Scientist II - Manager, PD Upstream
Core
Senior-level technical contributor leading upstream process development, scale-up, and technology transfer for AAV manufacturing to enable gene therapies.
Role type
Senior IC process development scientist (upstream)
Builds
AAV manufacturing processes and gene therapy products
Domain
Biotechnology / Gene Therapy / Upstream Process Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Upstream process strategy, complex experimental design, DoE studies, scale-up execution, technology transfer, regulatory documentation, cross-functional liaison, mentoring
Preferred skills
GMP execution, technical reporting, problem-solving in scale-up
Technologies
cGMP facilities, AAV systems
Responsibilities
Lead process development activities for early- to late-stage programs including scale-up and technology transfer; Design and execute complex Design of Experiments (DoE) studies; Act as liaison between Process Development, Manufacturing, and Quality teams; Mentor junior scientists and associates; Anticipate challenges in upstream scale-up and develop solutions; Contribute scientific rationale for tech transfer packages and GMP documentation.