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
GMP facility operations
DoE and statistical analysis
cross-functional collaboration
adherent and suspension processes
Nice-to-have
experience with stable packaging cell lines
excellent English communication skills
project management skills
troubleshooting scale-up issues
Key Requirements
Master’s degree or above in related discipline
4+ years upstream process development experience
experience with late stage (Phase II/III), PPQ or commercial support