Process Development Senior Scientist
Core
Develop and characterize liquid formulations for biologics (enzymes, mAbs, peptides) and support commercial formulation development and fill/finish process engineering.
Role type
Senior IC process development scientist (biologics)
Builds
Stable, manufacturable drug products for late-stage biologics portfolio
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features
Required skills
Biologics drug product formulation, protein stability analysis, degradation pathway characterization, analytical strategy design, statistical data analytics, AI/ML application, regulatory document authoring, cross-functional collaboration
Preferred skills
Enzyme formulation expertise, fill-finish process engineering, technical transfer experience, statistical process control (SPC), experimental design, biophysical techniques (UPLC/HPLC, SEC, IEX, etc.), data visualization tools (Tableau, Spotfire), project management
Technologies
UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, Tableau, Spotfire
Responsibilities
Design and execute formulation and process development studies; apply scientific principles to develop and implement processes; integrate formulation, analytical, and process data; author regulatory sections for IND/marketing applications; support technology transfer and manufacturing operations; apply AI/ML for predictive modeling; lead cross-functional initiatives for process design improvement
Seniority
Senior, hands-on IC
