Principal Scientist, Early DCT Lead
Core
Lead integrated CMC teams to advance biologics from candidate selection through early clinical development and First-in-Human milestones.
Role type
Principal Scientist (R5) – Development and Commercialization Team (DCT) Leader
Builds
Non-oral drug products (injections, implants, inhaled, ocular) for biologics pipeline
Domain
Biopharmaceuticals / Biologics / CMC Development
Required skills
Biologics product development, Integrated CMC leadership, Matrix leadership, Cross-functional project management, Regulatory filings, Technology transfer, Drug delivery, Process development, Analytical methods, Quality by Design
Preferred skills
Late-stage development leadership, Launch readiness, mAbs/ADCs experience, Combination products
Technologies
Cell culture process development, Cell line development, Finite Element Analysis (FEA), Design of Experiments (DOE), Pharmacokinetics, Pharmacodynamics
Responsibilities
Lead matrixed CMC project teams and establish decision rights, Drive strategic alignment across Drug Substance, Drug Product, Analytical, Regulatory, and Manufacturing functions, Frame program decisions and mitigate risks, Provide drug product leadership for scalable process development and scale-up, Mentor scientists to support milestone completion
Seniority
Principal, strategy & mentorship