Senior Manager, Packaging Engineering

Job Summary

A company is looking for a Senior Manager, Packaging Engineering.

Key Responsibilities:

• Develop and optimize packaging solutions for drug/device combination products
• Manage shipping validation and transport qualification of temperature-controlled shipments
• Direct day-to-day project oversight, including material requirements, budgets, and timelines

Qualifications:

• MS/M. Eng. in relevant life sciences or engineering discipline with 5+ years of experience in cGMP of biologics, or a BS with 8+ years
• Experience in biologic/device combination product development and packaging
• Experience managing US/international CDMOs/CTLs
• Familiarity with shipping validation and container closure integrity standards
• Working knowledge of FDA and international cGMP regulatory guidelines