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
Required skills
cGMP manufacturing operations, contract manufacturer management, batch scheduling, regulatory compliance (FDA/ICH/EU), data analysis, documentation authoring, audit support, process improvement, stakeholder liaison
Preferred skills
Experience with CMOs/CROs, knowledge of formulation through final package, proficiency in Excel/Oracle/Visio
Technologies
Oracle, Excel, PowerPoint, Visio, Word
Responsibilities
Coordinate external manufacturing activities at contract sites, liaise between internal departments and external partners, lead sub-teams in continuous process improvements, lead or support investigations concerning external manufacturing, perform reviews of batch records, author documents and procedures, support audit operations, analyze data for trends
Seniority
Principal, hands-on IC with mentorship
