Principal 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 Scientist I, hands-on IC
Builds
Biologics drug products and sterile parenteral formulations
Domain
Biopharmaceuticals / Biologics
Required skills
Biologics drug product formulation, process development, scale-up, technology transfer, sterile manufacturing unit operations, characterization, scale-down modeling, simulation, batch record authoring, cross-functional team leadership
Preferred skills
Regulatory filing authoring, cGMP and regulatory guidance knowledge, third-party manufacturer management, quality risk management and control strategies
Technologies
None explicitly listed
Responsibilities
Represent Bio DPD in cross-functional Product Presentation and Device Strategy Team (PPDST) and CMC Team; communicate development plans, risks, and mitigation plans to stakeholders; support scale-up and technology transfer to internal and external manufacturing sites; lead design and execution of formulation and process development studies; initiate scientific initiatives to drive innovation
Seniority
Principal, hands-on IC
