Plan dual-path development strategies for adherent and suspension processes and assess platformization and scale-up pathways
Job Summary
Plan dual-path development strategies for adherent and suspension processes and assess platformization and scale-up pathways.
Lead or contribute to quality activities during manufacturing, including deviation investigations, change control, and CAPA.
Serve as the upstream technical representative and collaborate cross-functionally with DSP, Analytical Development, Manufacturing, and QA/RA on program execution.
Matching Summary
Plan dual-path development strategies for adherent and suspension processes and assess platformization and scale-up pathways.
Skills & Requirements
Must-have
Upstream process development
Scale-up and tech transfer
Single-use bioreactor platforms
Process optimization and robustness
Cross-functional collaboration
Statistical analysis and DoE
GMP manufacturing operations
Nice-to-have
Experience with stable packaging cell lines
Excellent English communication skills
Strong project management skills
Late-stage regulatory filing support
Key Requirements
Master’s degree or above in related discipline
4+ years upstream process development experience
Experience in gene therapy or viral vectors
Dual-track adherent and suspension process development
Led scale-up and tech transfer projects
Late stage (Phase II/III), PPQ, or commercial support experience