Drug Product Associate, Sterile Drug Product
Core
Provide on-floor technical support and operational execution for sterile drug product manufacturing processes including formulation, filling, lyophilization, and packaging in a new commercial facility.
Role type
Manufacturing Associate (Sterile Drug Product)
Builds
Commercial sterile drug products (vials and syringes) for patient use
Domain
Pharmaceutical manufacturing / Sterile Drug Product
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
High-speed manufacturing experience, technical troubleshooting, process validation support, batch report review, lean principles application, process automation systems proficiency
Preferred skills
Science or engineering qualification, sterile drug product manufacturing expertise, capital/tech transfer experience
Technologies
Process automation systems, 5S, Standard Work, LSW, Kaizen
Responsibilities
Execute commercial manufacturing processes (Formulation, Filling, Lyophilization, Capping, Visual Inspection, Primary Packaging), troubleshoot technical issues, support commissioning/qualification/validation, assist with batch and exception reports, implement operational excellence initiatives, deliver training to SDP team
Seniority
Individual Contributor, Start-up environment