Job Title: Senior Manager QC Microbiology, (Hopewell, NJ)

Role: Manager of QC Microbiology Environmental Monitoring and Utilities Sampling programs in a biopharmaceutical setting, ensuring compliance with FDA/EU regulations. Responsibilities: lead environmental and utility sampling, author and review deviation and trend reports, oversee microbiology testing supporting GMP manufacturing, manage laboratory operations, and lead investigations of OOS and deviations; build and mentor a microbiology team, support regulatory inspections, and optimize laboratory efficiency. Requirements: Bachelor's in Microbiology or Biotechnology; 7+ years in biological drug QC within FDA-regulated biotech/pharma environments; 5+ years in management; expertise in environmental monitoring, microbial testing, and microbiology equipment; strong knowledge of cGMP/EU GMP, USP/EP standards; experience with electronic systems (LIMS, MODA); excellent leadership, communication, analytical, and project management skills. High-Value: microbiology, environmental monitoring, utilities sampling, biological drug QC, GMP compliance, team leadership, regulatory inspection support. WorkSetup: On-site with approximately 10% travel.