Director, Packaging Engineering

Lead packaging process development, scale-up, and optimization for OSD drug products. Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations. Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements. Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness. Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs. Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity. Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries. Support or participate in PAIs and other regulatory interactions related to packaging. Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations. Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs. Drive continuous improvement across packaging operations, materials, and systems. Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Regulatory, Formulation, and Analytical Development to ensure packaging readiness across all development and commercial stages.