Director, Sterility Assurance
Core
Manages the Aseptic Core Monitoring (ACM) program, oversees contamination control and aseptic practices, and ensures the production site is inspection-ready for biopharma clients.
Role type
Senior IC Director of Sterility Assurance
Builds
Aseptic production environments and contamination control programs for biopharma clients
Domain
Biopharmaceutical manufacturing / Aseptic processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic process monitoring, contamination control strategy, risk assessment, regulatory compliance interpretation, QMS data management, cross-functional leadership, cleanroom gowning protocols, environmental data trending
Preferred skills
Industrial microbiology background, Contract Manufacturing experience, advanced degree in life sciences or engineering
Technologies
eQMS, process mapping tools, risk assessment software, data analysis platforms
Responsibilities
Manage the Aseptic Core Monitoring (ACM) program and witness aseptic processes; Develop technical acumen in direct reports regarding contamination control; Oversee execution of EMPQ and APS processes; Support audits, deviations, and CAPAs with risk assessments; Perform trending and reporting for environmental data; Own cleaning and disinfection programs; Demonstrate commitment to being on the production floor with operators.
Seniority
Director, strategic oversight with hands-on floor presence
