Senior Manager, Sterility Assurance
Core
Managing sterility assurance and contamination control for a CAR T cell therapy manufacturing site, including aseptic process validation, facility design, and critical utilities monitoring.
Role type
Senior Manager, Sterility Assurance
Builds
Supports CAR T manufacturing operations and regulatory compliance
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, Microbiology, Aseptic process validation, Data integrity, Statistics, Change control management, Regulatory inspection support, Team leadership
Preferred skills
Cell therapy product experience, Regulatory audit participation, Quality systems expertise
Technologies
eQMS, Microsoft Office Suite
Responsibilities
Manage sterility assurance program and contamination control strategy; Support facility design, modifications, and aseptic process validation; Act as SME during regulatory inspections; Manage SOPs, deviations, and CAPAs; Lead and develop direct reports; Monitor critical utilities and support final product release
Seniority
Senior, hands-on IC with management responsibilities
