B87 Filling and Form Manager 3rd Shift
Core
Lead startup operations for aseptic filling and formulation in a new biopharma facility during commissioning and qualification phases.
Role type
Senior IC Production Manager (Aseptic Filling & Formulation)
Builds
Aseptic filling and formulation operations for biopharmaceutical products
Domain
Biopharmaceutical manufacturing (Aseptic processing)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing operations, GMP compliance, Regulatory readiness, Team leadership, Digital transformation, Process optimization, Problem solving, Cross-functional collaboration, Data analytics, Change management
Preferred skills
Industry 4.0 principles, SMS 2.0 standards, eBR approval, Real-time problem solving
Technologies
SAP, Qualipso, Ocularis, eOOE, iObeya, Sartocheck, Paltronic, Ops Tracker
Responsibilities
Lead facility startup, commissioning, and qualification phases; Execute media fills and PPQs; Ensure GMP and regulatory inspection readiness; Drive digital-first operational improvements; Build and develop high-performing operations teams; Solve complex operational challenges in real-time.
Seniority
Senior, hands-on IC