Director Non-Sterile Operations

Position Summary

The Director, Non-Sterile Operations provides strategic and operational leadership for non-sterile manufacturing operations, with primary accountability for packaging, inspection, and device assembly, including Auto Injector Assembly. The role also oversees Oral Solid Dose (OSD) and Continuous Manufacturing (CM) platforms as part of the site's non-sterile portfolio.

This position ensures the safe, compliant, and efficient execution of manufacturing and packaging activities from development through commercialization. The Director drives operational excellence and continuous improvement while partnering cross-functionally to deliver performance across safety, quality, delivery, cost, and people in alignment with evolving site priorities and growth platforms.

Key Responsibilities

• Lead and oversee non-sterile operations with primary focus on primary and secondary packaging, inspection, and Auto Injector Assembly, while maintaining operational excellence across OSD and Continuous Manufacturing platforms.
• Own operational performance across safety, quality, delivery, cost, and people, driving accountability and measurable results.
• Strengthen packaging, inspection, device assembly, OSD, and CM capabilities through operational rigor, process robustness, and appropriate technology enablement.
• Ensure sustained cGMP compliance through strong quality systems, documentation practices, investigations, CAPA, and risk management.
• Support technology transfer, scale-up, and commercialization activities across packaging, device assembly, OSD, and CM programs.
• Develop high-performing teams and foster a culture of engagement, accountability, and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Operations Management, or related field (or equivalent experience).
• 10+ years of progressive operations leadership experience in pharmaceutical or biopharmaceutical manufacturing, including sterile manufacturing in a regulated environment.
• Demonstrated experience in a cGMP-regulated environment, including strong understanding of regulations governing sterile injectable packaging, combination products, and medical device manufacturing (e.g., FDA 21 CFR Parts 210/211, 820, EU GMP, and applicable ISO standards).
• Experience with automated assembly systems, high-speed packaging lines, continuous manufacturing technologies, and continuous improvement methodologies preferred.
• Strong leadership, financial, and strategic acumen with the ability to influence stakeholders and build high-performing teams.
• Ability to travel up to 25% including international locations.