Principal Scientist, Early DCT Lead
Core
Direct the strategy and execution of biologics drug substance programs from candidate selection through early clinical development and First-in-Human milestones, establishing robust processes for late-stage development and commercialization.
Role type
Principal Scientist, Early DCT Lead (Biologics CMC)
Builds
Clinical drug substance supply and phase-appropriate manufacturing processes for biologics
Domain
Biopharmaceuticals / Large Molecule Drug Substance Development
Required skills
Integrated CMC and Matrix Leadership, Biologics Drug Substance Development, Regulatory Strategy and Authoring, Risk-Based Decision Making, Communication and Influence, Delivery and People Leadership
Preferred skills
Accelerated development approaches, Complex biologic modalities (bispecific antibodies, ADCs, fusion proteins)
Technologies
Cell Culture Process Development, Cell Line Development, Drug Formulations, Finite Element Analysis (FEA), Quality by Design, Technology Transfer
Responsibilities
Lead assigned early-stage Development and Commercialization Teams (DCTs) with accountability for integrated CMC strategy and milestone readiness; Define phase-appropriate drug substance strategies covering cell line, upstream, and downstream process development, scale-up, and technology transfer; Lead or support the strategy and preparation of drug substance content for global submissions including INDs and IMPDs; Coach early-career scientists and functional leads to strengthen scientific depth and execution capabilities.
Seniority
Principal, strategy & mentorship