NPI Product Lead

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.

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Job Description

We have an exciting new opportunity for an NPI Product Lead to join our Technical Operations team in Sligo. This position reports to the NPI Technical Manager. The successful candidate will provide technical support and day-to-day program management to all NPI across the site.

Roles and Responsibilities

• Lead and support New Product Introduction activities for product, processes, and technologies from early-stage development through PPQ.
• Provide technical direction, oversight, and coordinate support for NPI activities within biological manufacturing area.
• Work closely with internal and external program management to ensure alignment on NPI schedules.
• Resource planning to ensure the required personnel are available to support manufacturing operations during NPI executions and ensure operations run safely and efficiently.
• Provide direct interface as a subject matter expert with QA department, HPRA, FDA and applicable health authority and internal audits.
• Drive innovation and continuous improvement.
• Provide leadership and mentoring for operations personnel during NPI activities.
• Collaborate closely with external partners to ensure engagement, alignment, and open communication during NPI activities.
• Collaborate with external and internal partners to influence the design and implementation.
• of robust process control strategies and process risk assessments.
• Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
• Ensure ongoing compliance with cGMP and EH&S practices.