Operations Readiness Lead

Role

Lead the design and setup of manufacturing operations for parenteral drug products in a new facility, ensuring compliance with cGMP, ISO, and regulatory standards.

Responsibilities

• oversee process design, construction support, operational planning, continuous improvement culture, team development, and project leadership
• support technology transfer, commissioning, qualification, and validation activities.

Requirements

• Bachelor’s in engineering, science, or related field
• minimum 12 years in pharmaceutical or GMP operations with expertise in parenteral manufacturing
• proven leadership in transformational change, cross-functional collaboration, and team building.

HighValue

• parenteral drug products, GMP compliance, greenfield project leadership, site construction, Wilson NC location with >75% travel during design phase, on-site support.

WorkSetup

full-time on-site in Wilson, NC; frequent travel during project development.