Process Development Senior Scientist
Core
Develop, characterize, and scale-up drug substance processes for biologics to enable commercial advancement from late-stage clinical trials to marketing application.
Role type
Senior IC process development scientist (biologics)
Builds
Robust cGMP manufacturing processes for antibodies, oncolytic viruses, bispecifics, and siRNAs
Domain
Biopharmaceuticals / Bioprocessing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug substance process development, scale-up, cell culture, purification, cGMP manufacturing, regulatory submissions (CMC), design of experiments, statistical analysis
Preferred skills
Bioreactor process development, cell line development, protein characteristics understanding, leadership of scientific teams, peer-reviewed publications, cross-functional collaboration
Technologies
Bioreactors, cGMP manufacturing systems
Responsibilities
Apply platform approaches to solve drug substance challenges, drive innovation in technology development, collaborate cross-functionally with analytical and drug product teams, author technical reports and CMC regulatory submissions
Seniority
Senior, hands-on IC
