Assoc Director, Outsourced Manufacturing
Core
Manage outsourced manufacturing operations for Oral Solid Dose (OSD) pharmaceutical products to ensure compliance with registered processes and Master Production Records.
Role type
Senior Associate Director, Outsourced Manufacturing
Builds
OSD drug products for commercial launch and routine supply
Domain
Pharmaceutical manufacturing / Contract Manufacturing Organizations (CMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical GMPs, ICH guidelines, CMO management, vendor negotiation, supply chain execution, regulatory compliance, cross-functional team leadership, financial reporting
Preferred skills
OSD drug product manufacturing experience, CMO landscape knowledge, cGMP application, regulatory inspection support, supplier performance management
Technologies
None explicitly listed
Responsibilities
Execute tactical management of CMOs for OSD products; resolve complex manufacturing and compliance issues; coordinate technical transfers; foster continuous improvement; represent manufacturing on cross-functional teams; negotiate vendor costs; facilitate production schedules; support resource planning and financial reporting.
Seniority
Senior, hands-on IC with strategic oversight