Associate Director, Sterility Assurance
Core
Senior technical role accountable for the design, implementation, and oversight of the site's Contamination Control Strategy (CCS) program to ensure sterility assurance activities align with regulatory expectations and aseptic manufacturing best practices.
Role type
Senior IC sterility assurance director (pharmaceutical manufacturing)
Builds
Sterility assurance programs, contamination control strategies, and aseptic manufacturing processes for mRNA therapeutics
Domain
Biopharmaceuticals / Aseptic Manufacturing / Contamination Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination Control Strategy (CCS) design and implementation, Aseptic process execution oversight, Environmental Monitoring (EM) program management, Root cause analysis and CAPA leadership, Regulatory inspection readiness, Risk assessment facilitation, GxP compliance, Quality System documentation ownership, Floor audit and observation, Change control management
Preferred skills
Isolator-based manufacturing expertise, Master's or Ph.D. in Microbiology/Life Sciences/Pharmacy, Direct involvement in regulatory inspections, Media fill failure investigation
Technologies
Isolators, Cleanroom environments, GMP systems, Quality Management Systems
Responsibilities
Lead and maintain the Contamination Control Strategy (CCS) for the manufacturing site, Provide expert sterility assurance guidance on the Environmental Monitoring (EM) program, Lead or support investigations with potential impact to sterility assurance, Conduct routine floor audits and observations to assess aseptic behaviors, Coach operations and support personnel to reinforce sterile execution culture, Serve as subject matter expert for CCS, EM, aseptic execution, and isolator operations
Seniority
Senior, hands-on IC
