Senior Manager, Packaging, Aseptic
Core
Lead technical workstreams for aseptic filling line design, equipment integration, and process validation to support the startup of a new manufacturing campus for immunology, oncology, and neuroscience medicines.
Role type
Senior Manager, Aseptic Packaging & Filling Line Technical Lead
Builds
Aseptic manufacturing facilities, filling lines, and sterile fill-finish processes for biologics and drug products
Domain
Pharmaceutical manufacturing (Immunology, Oncology, Neuroscience)
Required skills
Aseptic sterile fill-finish expertise, GMP manufacturing experience, Process validation, Equipment design and integration, Cross-functional technical leadership, Risk management, Process optimization, Deviation investigation, Technical documentation
Preferred skills
Startup facility experience, Experience in drug substance or drug product manufacturing
Technologies
Filling line equipment, Automation systems, GMP compliance tools
Responsibilities
Define operating ranges, critical parameters, and acceptance criteria for aseptic processes; Lead technical evaluation and integration of filling-line equipment with facility systems; Ensure design supports aseptic processing, GMP, and contamination-control objectives; Provide technical leadership through equipment testing, startup, and process validation; Guide engineers through technical decisions and document decision logic; Analyze performance data and draft corrective actions for deviations
Seniority
Senior Manager, Startup Leadership