Senior Principal Scientist, Large Molecule Drug Product Scientific Integrator
Johnson & Johnson
Malvern, Pennsylvania, United States of America
Hybrid
Large molecule drug product development
Late-stage program integration
Global cmc team leadership
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
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.
We provide an inclusive work environment where each person is considered as an individual.
Matching 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.
Skills & Requirements
Must-have
large molecule drug product development
late-stage program integration
global CMC team leadership
regulatory submission authoring
scientific risk assessment
Nice-to-have
health authority interaction experience
complex delivery systems familiarity
mentoring and capability development
Key Requirements
PhD with 6+ years experience or Master's with 10+ years experience
Late-stage, registration, and/or commercial program experience
Experience leading Drug Product strategy on global CMC teams
Strong background in CMC regulatory strategy
Experience with technology transfer and process validation