Sr. Manager Lab Operations - Bioburden
Core
Lead day-to-day operations for the Bioburden department, overseeing microbiological testing for radiation sterilization validations and measuring sterilization effectiveness for medical device and pharmaceutical products.
Role type
Senior Manager, Lab Operations (Bioburden)
Builds
High-quality microbiological testing services and sterilization validation data
Domain
Medical device and pharmaceutical manufacturing, radiation sterilization, regulated laboratory environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory operations management, Manufacturing operations leadership, Team leadership in regulated environments, Microbiology knowledge, Validation experience (equipment and facility), Budget planning, Process improvement, GMP/GLP/ISO compliance
Preferred skills
Tissue manufacturing experience, Radiation sterilization environment experience, Medical device or pharmaceutical manufacturing background
Technologies
Co-60 irradiators, gamma sterilization equipment, microbiological testing systems
Responsibilities
Lead day-to-day laboratory operations for the Bioburden department, Drive departmental KPIs including quality, turnaround times, utilization, and operational efficiency, Lead, coach, and develop managers and laboratory staff, Ensure compliance with GMP, GLP, ISO, and applicable regulatory standards, Partner cross-functionally with Quality, Sales, Consulting, and Operations leadership, Support profitable growth initiatives and expansion of laboratory capabilities
Seniority
Senior, hands-on IC with people management