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)
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