Packaging Development Manager Alexion Technical Operations (ATO)

at  Alexion PharmaceuticalsInc

THIS IS WHAT YOU WILL DO:

The successful candidate will have packaging developing oversight for pack design, external manufacturing and regulatory inputs to drive the design towards a commercial pack. The role will require access to software platforms for review and approval of technical profiles which underpin commercial package components. This position provides strong packaging technical support through all phases of the commercial finished product lifecycle, including technology transfer, validation, and routine Finished product (FP) for commercial manufacturing
As a team, we build and maintain effective cross-functional working relationships with groups finished product (FP) subject matter experts, New Product Introduction (NPI), Internal/External Manufacturing Operations, Quality, Marketing, Medical Devices and Regulatory partners for Packaging Technology Transfers and Launches of new and existing products, including biologics, small molecule and combination medical devices.

YOU WILL BE RESPONSIBLE FOR:

• Liase with the global team to create the best packaging form, fit, function and aesthetics for new and existing drug products under the Alexion Astra Zeneca brand.
• Responsible person for development, review and approval of packaging components from a technical perspective.
• Colloborating with different members across the Alexion/AZ network to operate on various software approval platforms particularly for Technical Profile Drawing Creation and Approval.
• Selecting, analysing and communicating on best possible material for use in packaging designs, awareness of leadtimes, sustainable practices and readiness against project plans.
• Leading troubleshooting and root cause analysis activities for critical issues at CMOs.
• Willingness to collaborate and engage on digitailsation projects within Packaging.
• Partner with product teams on optimal packaging design considering the end user/patient, supply chain, and FP manufacturing network capabilities.
• Acting as the technical SME for packaging transfers including global approval of transfer protocols, validation run protocols, technical study protocols and reports.
• Technical review and input into Change Controls, User Requirement Specifications, Risk Assessments and Packaging Tech Transfer Protocols, as applied to Packaging Transfers.
• Support resolution of complaints and liaise with vendors to resolve issues, investigations, and implement continuous improvements.
• Provide FP SME input for regulatory agency submission in support of FP manufacturing processes at internal/external FP manufacturing sites.
• Communicating operational status of CMOs regularly to management, as required, at the appropriate level of detail, both orally and using written documents, and in formal and informal presentations.
• Up to 20% international travel may be required