Microbiology Manager (Langhorne, PA) - Act as Subject Matter Expert (SME) and lead coordinator for critical microbiological quality control projects, including Microbial Limit Testing (MLT), bioburden tests, bacterial endotoxin testing, sterility testing, Total Aerobic Microbial Count (TAMC), coliform detection, endotoxin challenge recovery evaluations, OOS/OOT investigations, and biological indicator performance verification testing; Lead in critical analysis of quantitative and qualitative microbiological testing of pharmaceutical drug products and raw materials in compliance with FDA/GMP, using aseptic processing techniques; Perform method validation on Bacterial Endotoxin Testing (BET) for raw materials, packaging materials and pharmaceutical finished drug products; Perform Microbial Limit and Bioburden tests using Vitek 2 analyzer; Execute EMPQ and gowning qualification programs in compliance with ISO-5/6/7/8; Conduct sterility testing within validated BioQuell Isolators under strict aseptic conditions to ensure product sterility assurance levels; Maintain the Quality Management System (QMS) within Master Control, ensuring compliance with 21 CFR Part 11 and regulatory audits; Lead investigations and root cause analyses of laboratory deviations and nonconformances, using CAPA; Supervise 5 Microbiologists. Require skills and working knowledge of BET, MLT/Bioburden Tests, ISO-5/6/7/8, EMPQ, method validation, QMS, OOS/OOT, Aseptic Processing.