• Provide packaging support to the drug product development project teams, clinical and global supply chains (CSC and GSC) to ensure:
• Development requirements to support that qualification, registration, and launch key events are met. Activities include, but are not limited to:
• Coordinate, execute and document experiments for selection and use of primary packaging and administration components
• Complete primary packaging specifications
• Recommend primary packaging components
• Manage/complete stability packaging campaigns
• Complete (generate or review) IND/NDA CTA/MAA Container Closure sections with supporting documentation
• Review of post launch primary packaging changes or stability issues, as needed or requested.
• Cost effective package development.
• Alignment of primary pack component usage throughout R&D Pharma, GSC and with Global Procurement input/support to ensure cost effective solutions (i.e., material selection and process)
• Assessment of new materials, components, and technologies for both technical performance and cost effectiveness.
• Support the development of strategies on package development and technology across the PD, NPS, GMS, Commercial, and external interfaces to ensure effective PD Product Development Support:
• Globally harmonized and coordinated strategies for pack development activities
• Packaging input to lean manufacture/packaging
• Providing competitive advantage through packaging
• Industry and global developments in packaging, and their adoption to support NPS
• Assessment of external partnering and collaborations
• Support the development and execution of Global Manufacturing Supply Procurement strategies and sourcing groups
• Support the development of regulatory, quality, and legislative strategies for packaging to ensure cost effective development:

• B.S./M.S. degree in Packaging Engineering/Packaging Science, Chemistry, Life Science, or equivalent industry experience, with minimum 1 year experience in package development, primarily in pharmaceutical industry. Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, New Product Introduction and technology transfer processes.
• Demonstrated ability to perform good experiment documentation meeting data integrity expectations.
• Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.
• Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.
• Working knowledge of packaging materials, components, vendors, equipment, legislation, regulations, and technologies and the ability to apply this knowledge to satisfy project goals within PD and GMS.
• Demonstrated knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).
• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.

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