B87 Filling and Formulation Manager
Core
Lead aseptic filling and formulation operations during facility startup, commissioning, and qualification phases to achieve commercial readiness.
Role type
Senior IC manufacturing operations manager (aseptic filling and formulation)
Builds
Aseptic filling and formulation lines 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 systems proficiency, problem solving
Preferred skills
facility startup/commissioning experience, media fill execution, Lean manufacturing, Industry 4.0 concepts
Technologies
SMS 2.0, eOOE, iObeya, SAP, Qualipso, Ocularis, Sartocheck, Paltronic, Ops Tracker
Responsibilities
Lead startup operations through commissioning and qualification; Drive execution of Development Aseptic Process Simulations (media fills) and PPQs; Ensure strict GMP compliance and regulatory readiness; Own shift performance for aseptic filling and formulation; Build and develop a high-performing operations team; Champion digital-first approaches and continuous improvement.
Seniority
Senior, hands-on IC
