Principal Scientist, Large Molecule Drug Product Scientific Integrator

Principal Scientist, Large Molecule Drug Product Scientific Integrator (Late Stage) located in Malvern, PA. Own end-to-end scientific integration for late-stage large-molecule drug product programs, serving as the primary Drug Product scientific lead for assigned programs, leading cross-functional sub-teams across formulation, manufacturing process, analytical, delivery system, quality, regulatory, and supply chain. Define and maintain DPD&D CMC strategy, prepare global regulatory submissions (BLA/MAA and post-approval filings), and drive registration-to-lifecycle execution. Partner with manufacturing sites for technology transfer, process validation, launch readiness, and lifecycle improvements. Mentor scientists, foster cross-program scientific capabilities, and contribute to continuous improvement. Required: PhD with 4+ years or MS with 6+ years in biopharmaceutical development; extensive experience in large-molecule drug product development, global CMC team leadership for parenteral biologics, regulatory strategy (IND/IMPD, BLA/MAA, sBLA), control strategy, comparability, lifecycle management, manufacturing collaborations, IP-related questions, and strong communication skills. Travel ~10–20% expected. Johnson & Johnson is an Equal Opportunity Employer.