Site Engineering Manager, Manufacturing (Isotopes)
Core
Lead engineering strategy and operations for a radioligand therapy isotope manufacturing facility, ensuring equipment reliability and GMP compliance.
Role type
Senior manufacturing engineering manager (pharmaceutical/biotech)
Builds
Radioligand therapy isotope manufacturing operations
Domain
Pharmaceutical/Biotechnology manufacturing
Required skills
GMP compliance, equipment reliability, capital project management, team leadership, regulatory investigations, budget management, vendor management
Preferred skills
Process engineering, maintenance strategy, automation, risk management
Technologies
GAMP5, Title 21 CFR Part 11, FDA regulations
Responsibilities
Provide strategic leadership for Process Engineering and Maintenance; coach and develop technical teams; drive equipment reliability strategies; oversee commissioning, qualification, and validation; lead engineering investigations and change controls; manage departmental budgets and procurement.
Seniority
Senior, hands-on IC with people leadership