Principal Scientist, Early DCT Lead
Core
Lead integrated CMC programs for early-stage biologics from candidate selection through First-in-Human milestones while serving as an analytical SME for method development and control strategies.
Role type
Principal Scientist, Early-Stage DCT Lead (Integrated CMC & Analytical Development)
Builds
Pipeline biologics (mAbs, multispecifics, fusion proteins) advancing to clinical development and commercialization
Domain
Biopharmaceuticals / Biologics Development
Required skills
Integrated CMC program leadership, Biologics analytical development, Advanced characterization (biophysical/biochemical), Regulatory dossier authoring, Risk management, Matrix stakeholder influencing, People mentorship
Preferred skills
Accelerated development paradigms, Complex biological modalities (ADCs, bispecifics)
Technologies
U/HPLC, SEC, IEX, HIC, RP, CE-SDS, cIEF, Mass Spectrometry, CD, DSC, DLS, AUC, ELISA, SPR
Responsibilities
Lead DCT teams for assigned pipeline biologics, Define analytical control strategies and CQAs, Author regulatory filings (IND/IMPD), Mentor early-career scientists, Manage cross-functional alignment and program risk
Seniority
Principal, hands-on IC with strategic leadership