Quality Compliance - Associate Director - Microbiology
Core
Subject matter expert in microbiology and contamination control supporting QC labs, manufacturing, and site teams to ensure science-based, compliant decisions.
Role type
Associate Director, Quality Compliance Microbiology
Builds
Global microbiology and contamination control standards, procedures, and quality intelligence documents for Amgen's biotech operations.
Domain
Biotechnology / Pharmaceutical Manufacturing / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology subject matter expertise, Contamination control program management, Environmental monitoring, Bioburden control, Endotoxin testing, Microbial identification, Disinfectant efficacy, Aseptic practices, GMP compliance, Regulatory inspection readiness, Cross-functional leadership, Technical documentation review
Preferred skills
Sterile manufacturing experience, Biologics processing, Laboratory automation, Rapid microbiological methods, Global technical network participation, Risk assessment, Change control management, Audit response leadership
Technologies
Laboratory automation tools, Data trending tools, Rapid microbiological methods
Responsibilities
Support contamination control program including site engagement, metrics review, and risk identification; Develop and implement global microbiology standards and procedures; Provide technical input for environmental monitoring, bioburden, endotoxin, and aseptic practices; Lead or support cross-functional projects related to inspection readiness and quality improvement; Review regulatory filings and technical documents for microbiology content; Monitor regulatory developments and translate into practical site expectations.
Seniority
Associate Director, hands-on technical leadership with people management
