Job Summary

• The Director serves as a member of the plant senior leadership team responsible for technical transfer and validation operations for sterile injectable products.
• This role requires establishing validation strategies that comply with global regulatory requirements including FDA, EMEA, PIC/S, and Japan PMDA standards.
• Candidates will manage a budget exceeding $10 million while leading cross-functional teams through complex technical challenges in a cGMP environment.

Matching Summary

Salary

Not specified; Not specified; Day One Benefits include Medical & Dental, 401(k) match, Paid Time Off, and Employee Ownership Plan

Skills & Requirements

Key Requirements

• Bachelor's Degree in science or engineering
• Minimum 10 years aseptic manufacturing operations
• Minimum 8 years technical management experience
• Strong knowledge of aseptic processing validation
• Ability to meet Grade C gowning requirements

Work Rights