Quality Compliance Associate Director - Aseptic Processing
Core
Subject matter expert in aseptic processing and contamination control ensuring science-based, compliant decisions across Amgen Operations.
Role type
Associate Director, Quality Compliance (Microbiology)
Builds
Global aseptic processing standards, contamination control programs, and inspection readiness for sterile manufacturing.
Domain
Biopharmaceutical manufacturing / Sterile processing / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing expertise, Contamination control management, Microbiology subject matter expertise, GMP compliance, Risk assessment, Regulatory inspection readiness, Cross-functional leadership, Technical documentation, Change control management, Audit response
Preferred skills
Biologics manufacturing experience, Sterile drug product manufacturing, Environmental monitoring programs, Rapid microbiological methods, Automation in manufacturing, Global technical network participation, Multi-site standards development
Technologies
Environmental monitoring tools, Data trending tools, Rapid microbiological methods, Automation systems
Responsibilities
Serve as aseptic processing and contamination control subject matter expert, Support contamination control program including site engagement and risk identification, Contribute to development of global aseptic processing standards, Provide technical input for environmental monitoring and microbial identification, Partner with site teams to promote consistent contamination control application, Provide technical review for investigations and CAPAs, Support regulatory inspections and audit readiness, Monitor regulatory developments and translate to practical expectations, Lead cross-functional projects related to aseptic processes.
Seniority
Associate Director, hands-on IC with leadership responsibilities
