Associate Director, QC Environmental Monitoring (EM) & Sterility
Core
Design, develop, and oversee Environmental Monitoring (EM) and Sterility Testing programs for a biologics manufacturing facility, ensuring compliance with cGMP and supporting the commercialization of high-potential compounds like Antibody Drug Conjugates.
Role type
Associate Director, QC Environmental Monitoring & Sterility
Builds
EM and sterility testing infrastructure, SOPs, and a team of analysts for a new biologics manufacturing site
Domain
Pharmaceutical Biotechnology / High Potent Compounds
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Environmental Monitoring program design, Sterility testing (USP <71>), Facility start-up (EMPQ), Root cause analysis, SOP development, LIMS, Microbiology instrumentation, Regulatory compliance (cGMP, EU Annex 1)
Preferred skills
Rapid microbiological methods, EM automation, Data analytics, People management, Change control
Technologies
LIMS, MODA, Isolators, Incubators, Autoclaves, Particle counters
Responsibilities
Design and implement EM sampling strategies and sterility testing protocols; Lead facility start-up activities including equipment qualification and commissioning; Perform routine EM sampling and sterility testing; Lead investigations for EM excursions and sterility failures; Recruit and manage a team of analysts as the site scales
Seniority
Senior, hands-on IC transitioning to people leadership
