AssociateDirector,TechnicalOperations(PharmaceuticalPackaging)

## Accountabilities Lead the design, development, and finalization of pharmaceutical packaging systems, including primary and secondary packaging, labels, cartons, shippers, and ancillary components, ensuring patient usability, product protection, and regulatory compliance. Oversee packaging engineering activities such as specifications development, component selection, material compatibility, and documentation of packaging drawings, bills of materials, and instructions. Drive packaging innovation, including sustainable materials and human factors–driven designs that support patient adherence and usability. Lead packaging technology transfer from development to clinical and commercial manufacturing, ensuring seamless implementation with external partners and CPOs. Manage packaging qualification and validation activities, including transportation simulation studies, distribution qualification, and cold chain shipping validation. Ensure serialization, traceability, and labeling compliance across global regulatory frameworks, including DSCSA and other applicable requirements. Support quality and regulatory activities including audits, inspections, deviation investigations, CAPA, change control, and regulatory submissions related to packaging systems. Oversee lifecycle management of packaging systems, including continuous improvement, optimization, and post-launch updates. Requirements: Bachelor’s or Master’s degree in Packaging Engineering, Mechanical Engineering, Chemical Engineering, Industrial Design, or a related technical field; advanced degree preferred. Minimum of 8+ years of experience in pharmaceutical, biotech, or medical device packaging, including clinical and commercial environments. Proven experience in packaging design, validation, qualification, and technology transfer within regulated environments. Strong understanding of pharmaceutical packaging systems, including sterile barrier systems, cold chain logistics, and distribution requirements. Deep knowl