Associate Director Packaging Development

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The Associate Director, Packaging Development is a senior-level individual contributor within the Packaging Development organization, responsible for providing technical leadership for packaging development, qualification, and commercialization activities for combination products.

This position serves as the subject matter expert (SME) responsible for defining packaging strategies that support successful regulatory submissions and commercialization of combination products.

This role will shape and define combination product packaging processes and establish the governance and operating framework for Packaging Engineering across the combination product ecosystem. The Associate Director will serve as the primary Packaging Engineering representative within the combination product ecosystem, driving cross-functional alignment and resolution of complex technical and organizational issues.

In addition, while serving as the Combination Product Packaging SME, this role will independently lead packaging development programs across multiple product modalities and may be accountable for development, qualification, and commercialization activities supporting biologics and oral solid dose (OSD) products based on business priorities and organizational needs.

The role operates with a high degree of independence, provides technical mentorship to other engineers, and helps define the long-term operating model for Packaging Engineering within the combination product ecosystem.

This is an on-site role, located at Gilead headquarters in Foster City, California.

Provide vision and leadership to build and integrate combination product packaging development processes into the Gilead ecosystem.

Develop and maintain governance, roles, responsibilities, and decision-making processes that define interfaces between Packaging Engineering, Device Engineering, Device Quality, Regulatory Affairs, and other key stakeholders.

Define and continuously improve the operating model, workflows, and best practices that support effective execution and cross-functional collaboration across combination product, biologics, and pharmaceutical development programs.

Lead resolution of complex issues involving Packaging Engineering and cross-functional stakeholders.

Provide technical leadership during design reviews, risk assessments, change management activities, and governance forums.

Lead or support design control activities, ensuring packaging requirements are appropriately incorporated into design, risk management, verification, validation, and change management processes.

Participate in hazard analysis and risk assessments related to packaging and distribution.

Lead packaging development, qualification, and commercialization activities for assigned combination product, biologics, and OSD programs.

Assess packaging manufacturing networks, identify capability gaps, and develop strategies to support future portfolio needs.

Evaluate and…