Sterile Compounding Lead
Core
Lead sterile compounding operations in a 503A/503B environment, ensuring safe, compliant, and scalable execution of personalized medicine manufacturing.
Role type
Sterile Compounding Lead (Shift Supervisor)
Builds
Compliant sterile compounded preparations (CSPs) for patients and providers
Domain
Healthcare / Pharmaceutical Manufacturing / Sterile Compounding
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
Sterile compounding operations, cGMP, USP standards, aseptic technique, controlled environments, equipment use, documentation requirements, AI-enabled dashboards, workflow signals, trend analysis, digital tools, leadership, coaching, communication, escalation skills, deviation prevention, audit readiness, batch documentation, basic pharmaceutical calculations, resource coordination, continuous improvement
Preferred skills
Training and mentoring technicians, digital production systems, quality documentation platforms, data-driven performance management
Technologies
AI-enabled tools, digital production systems, quality documentation platforms, workflow dashboards
Responsibilities
Lead sterile compounding activities with disciplined adherence to cGMP and aseptic technique; Coordinate shift priorities, room readiness, staffing, and production handoffs; Verify materials, equipment, and cleanroom conditions before compounding; Reinforce frontline quality discipline through observation and coaching; Maintain inspection-ready execution for cGMP, USP, FDA, and state board standards; Train and mentor technicians on aseptic discipline and procedural accuracy; Partner with Quality, Training, and Production leaders to resolve constraints; Identify and escalate safety, quality, and process risks early; Lead practical improvements to reduce defects and improve flow.
Seniority
Mid-level, hands-on IC with shift leadership responsibilities
