Senior Manager, Global External Manufacturing- Sterile DP & Biologics
Core
Executing tactical manufacturing strategy and technical lifecycle management for sterile drug products and biologics within a global external contract manufacturing network to ensure uninterrupted clinical and commercial product supply.
Role type
Senior Manager, Global External Manufacturing (Sterile DP & Biologics)
Builds
Clinical and commercial sterile drug products and biologics for Gilead
Domain
Pharmaceutical manufacturing (sterile drug products and biologics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
sterile drug product manufacturing, supply chain execution, cGMP compliance, regulatory requirements (ICH), contract manufacturing organization (CMO) landscape, technology transfer, process validation, deviation investigation, master batch record management, regulatory filing support (CMC sections)
Preferred skills
bulk drug substance manufacturing, CMO capabilities assessment
Technologies
aseptic filling, lyophilization, terminal sterilization, visual inspection, sterility assurance, IQ/OQ/PQ
Responsibilities
Execute tactical manufacturing strategy and manage external resources; manage technical lifecycle including technology transfers, scale-up, and process validation; provide technical expertise in parenteral unit operations; co-lead commercialization activities at external partners; lead cross-functional CxO teams; perform technical investigations and assess deviations/CAPAs; define requirements and review master batch records; coordinate equipment/process qualification and process validation; maintain technical database for CMOs; support product CMC team and author regulatory filings; manage complex processes across functions; provide technical guidance and training to junior members.
Seniority
Senior Manager, hands-on IC with team leadership
