Manufacturing Changeover Manager - Drug Substance
Core
Planning, coordinating, and leading turnaround activities for Drug Substance/API operations to ensure safe, compliant, and efficient campaign transitions.
Role type
Manufacturing Changeover Manager
Builds
Repeatable and standardized turnaround models for small molecule facility operations
Domain
Biopharmaceutical manufacturing (Drug Substance/API)
Required skills
Turnaround planning, GMP compliance, Lean principles, Team leadership, Cross-functional coordination, Standard work development, Performance metrics tracking, Operational discipline, Problem-solving, Data-driven decision making
Preferred skills
Chemical or Pharmaceutical Engineering background, Experience in regulated manufacturing environments
Technologies
None explicitly stated
Responsibilities
Lead planning and execution of turnaround activities, Develop standardized turnaround models, Coach and develop mechanical, electrical, and operations teams, Partner with Production Lead and stakeholders, Monitor turnaround performance and identify improvement opportunities, Support day-to-day facility operations
Seniority
Mid-Senior, hands-on IC
