B87 Formulation and Filling Manager
Core
Lead startup operations for aseptic filling and formulation in a new biopharma facility, ensuring safety, quality, and compliance 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, startup/commissioning leadership, digital systems proficiency, team building, regulatory readiness, problem solving
Preferred skills
Facility/line startup experience, media fill execution experience
Technologies
SMS 2.0, eOOE, iObeya, SAP, Qualipso, Ocularis, Sartocheck, Paltronic, Ops Tracker
Responsibilities
Lead facility startup, commissioning, and qualification phases; Execute Development Aseptic Process Simulations (media fills) and Process Performance Qualifications (PPQs); Drive inspection readiness for regulatory audits; Optimize operations using digital tools and data analytics; Build and develop high-performing operations teams; Ensure strict GMP compliance and regulatory standards adherence
Seniority
Senior, hands-on IC
