Commercial Packaging Engineering Lead (Ex-US Supply)

What You'll Do

You lead commercial manufacturing and packaging for our products, with a particular focus on packaging and ex-US supply. You own the external network that turns bulk drug product into a compliant, serialized, market-ready commercial pack — managing artwork, serialization, packaging validation and the CMO partnerships. This role scales in step with our commercial expansion, you will help stand up the capability, not simply inherit it.

Responsibilities

• Own commercial packaging engineering — primary, secondary and serialized packaging — from design and qualification through steady-state supply, ensuring every configuration is manufacturable, compliant and patient-ready.
• Lead ex-US commercial manufacturing and distribution, managing CMOs with our international affiliates, and packaging partners across international markets to meet demand, quality and regulatory requirements.
• Own end-to-end artwork management.
• Own serialization and track-and-trace compliance (e.g. EU FMD, DSCSA and equivalent ex-US requirements), ensuring systems, master data and partners are aligned market by market.
• Lead packaging and process validation, protocols and change control in partnership with Quality and Regulatory, maintaining a state of inspection readiness.
• Manage the commercial manufacturing budget, capacity commitments and supplier performance, negotiating and governing agreements with external partners.
• Partner cross-functionally with Regulatory, Quality, Commercial and Supply Planning to support launches, market expansions and lifecycle changes on time and in full.

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor's degree in packaging engineering, engineering, pharmaceutical sciences or a related field; 10+ years in commercial pharmaceutical manufacturing and supply.
• Demonstrated packaging engineering background across primary and secondary drug-product packaging.
• Hands-on ex-US commercial manufacturing and distribution experience, managing CMOs and partners across international markets.
• Deep, practical expertise in artwork management, serialization / track-and-trace, and packaging & process validation.
• Strong command of GMP, change control and regulatory expectations for commercial packaging across multiple geographies.
• Experience launching a commercial product in the US and ex-US markets (EU, LATAM, Japan and others).
• Familiarity with EU FMD, US DSCSA and comparable global serialization regulations.
• Travel – 20%-25% total time will be used for travel