Senior Scientist II - Biologics Drug Product Development
Core
Lead biologics drug product formulation development, predictive stability modeling, and quality risk management for proteins, conjugates, peptides, neurotoxins, and genetic medicines.
Role type
Senior Scientist II, hands-on IC
Builds
Biologics drug products and formulations
Domain
Biopharmaceuticals / Drug Product Development
Deliverable
production ML models | product features
Required skills
Biologics formulation development, predictive stability modeling, quality risk management, in-use compatibility assessment, cross-functional team leadership, statistical/phenomenological/mechanistic modeling, AI/ML for stability
Preferred skills
cGMP and regulatory guidance knowledge, sterile manufacturing unit operations, third-party manufacturer management, drug product control strategies
Technologies
AAV, LNPs, Cell Therapy, AI/ML
Responsibilities
Lead matrix drug product teams for internal and external projects, design and execute formulation development and robustness studies, serve as subject matter expert in stability modeling and QRM, communicate development plans and risks to stakeholders
Seniority
Senior, hands-on IC