Principal External Manufacturing Specialist (Drug Product)
Core
Oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion, and monitoring cGMP compliance.
Role type
Principal External Manufacturing Specialist (Drug Product)
Builds
Contract manufacturing operations for life-changing medicines
Domain
Pharmaceutical manufacturing / cGMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing operations, regulatory compliance (FDA, ICH, EU), batch record review, audit support, data analysis, project coordination, stakeholder liaison
Preferred skills
Continuous process improvement, system/equipment implementation, strategy development, investigation leadership
Technologies
Oracle, Excel, PowerPoint, Visio, Word
Responsibilities
Coordinate external manufacturing activities at contract sites, liaise between internal departments and contract manufacturers, lead sub-teams in continuous process improvements, lead or support investigations concerning external manufacturing, perform reviews of pre-production and executed batch records, author documents and procedures, support audit operations, analyze data for trends and potential issues
Seniority
Principal, hands-on IC with mentorship
