Principal Scientist I, Biologics Drug Product Development
Core
Lead the design and execution of biologics drug product formulation, process development, characterization, and robustness studies for proteins, conjugates, peptides, neurotoxins, and genetic medicines.
Role type
Principal Scientist I, Biologics Drug Product Development
Builds
Biologics drug products and processes for internal and external manufacturing sites
Domain
Biopharmaceuticals / Biologics
Required skills
Biologics drug product formulation, process development, scale-up, technology transfer, sterile manufacturing unit operations, characterization, scale-down models, simulation, batch record authoring, regulatory filings for biologics, cGMP compliance, quality risk management, third-party manufacturer management
Preferred skills
Regulatory filing authoring, cGMP and regulatory guidance understanding, third-party manufacturer management, quality risk management and control strategies
Technologies
Freeze-thaw, compounding, mixing, filtration, filling, lyophilization, scale-down models, simulation
Responsibilities
Represent Bio DPD in cross-functional Product Presentation and Device Strategy and CMC teams, communicate development plans and risks to stakeholders, support scale-up and technology transfer activities, lead design and execution of formulation and process development studies, initiate scientific initiatives to drive innovation
Seniority
Principal Scientist I, hands-on IC with strategic collaboration