Principal Research Scientist I, Biologics Drug Product Development
Core
Lead biologics drug product formulation, process development, scale-up, and technology transfer for proteins, conjugates, peptides, neurotoxins, and genetic medicines.
Role type
Principal Research Scientist I (Biologics Drug Product Development)
Builds
Biologics drug products and sterile parenteral formulations
Domain
Biopharmaceuticals / Biologics / CMC
Required skills
Biologics formulation development, sterile manufacturing unit operations, scale-up and technology transfer, regulatory filing authoring, quality risk management, team leadership, cross-functional collaboration
Preferred skills
Ultra-high concentration liquid formulations, commercialization experience, third-party manufacturer management
Technologies
Lyophilization, filtration, compounding, mixing, freeze-thaw, scale-down models, simulation
Responsibilities
Lead design and execution of formulation and process development studies; Lead drug product process scale-up and technology transfer; Supervise a team of 2-3 scientists; Act as DP Team Lead in cross-functional teams; Author batch records and regulatory filings
Seniority
Principal, hands-on IC with team leadership