Job Summary

• This role provides single‑point accountability for Drug Product strategy within the global Chemistry, Manufacturing, and Control (CMC) team(s), ensuring alignment across formulation, process, delivery system, analytical, manufacturing, quality, regulatory, and supply chain functions.
• The Scientific Integrator plays a critical role in right‑first‑time registration, launch readiness, and lifecycle success, acting as a trusted scientific advisor and matrix leader across global teams.
• You will be responsible for authoring, reviewing, and approving drug product sections of global regulatory submissions, including BLA/MAA and post‑approval filings.

Matching Summary

Skills & Requirements

Key Requirements

• PhD with 6+ years experience or Master's with 10+ years experience
• Late-stage, registration, and/or commercial program experience
• Parenteral biologics experience
• CMC regulatory strategy
• Control strategy development

Work Rights