Senior Principal Scientist, Large Molecule Drug Product Scientific Integrator
J&J FAMILY OF COMPANIES
Malvern, Pennsylvania, United States of America
Hybrid
Large molecule drug product scientific integrator
Late-stage drug product programs
End-to-end scientific integration
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.
You will be responsible for defining and maintaining drug product CMC strategy, including control strategy, critical quality attributes, comparability, and post‑approval change planning.
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 Scientific Integrator
late-stage drug product programs
end-to-end scientific integration
global CMC team leadership
drug product strategy ownership
regulatory submission authoring
Nice-to-have
trusted scientific advisor
matrix leadership across global teams
mentoring and coaching scientists
organizational best practices
complex delivery systems experience
Key Requirements
PhD with 6+ years experience or Master's with 10+ years experience
Significant experience in large-molecule drug product development
Proven experience leading Drug Product strategy on global CMC teams
Strong background in CMC regulatory strategy
Experience partnering with manufacturing sites
Ability to influence, align, and lead through matrix teams