Overview

Title: Manager - Microbiology & Environmental Monitoring Location: NJ5 - Totowa, New Jersey Department: Radiopharmaceutical Contract Manufacturing Compensation Range: $110,000-$120,000/year Overview: The Microbiology - Environmental Monitoring Manager supports manufacturing activities at the NJ5 site by (1) detecting, quantifying, identifying and investigation possible contaminants that may impact the quality of product during different stages of the manufacturing process, (2) establishing and monitoring the state of microbiological control at the site, (3) assessing aseptic behavior and practices of site personnel and assessing the effectiveness of cleaning and sanitization programs at the site, and serving as site expert on the pharmaceutical/industrial microbiology. Essential Duties and Responsibilities Manages and maintains site environmental monitoring and sterility assurance programs by leading development, qualification and training efforts for Environmental Monitoring (EM), cleaning and sanitization, classified area gowning, media fills, and microbiology testing (including, but not limited to, sterility, endotoxin, microbiology method suitability, growth promotion, and isolate identification). Develop and manage departmental KPI for Safety, Quality and deliverables including but not limited to annual performance goals. Manages departmental resources and personnel, performs routine 1:1 meeting with direct reports, year-end reviews, and prepares team members for growth and advancement. Efficiently schedules resources, prioritizing between projects, clinical manufacturing, Quality needs, and other facility related tasks requiring control over aseptic conditions and environmental monitoring needs. Manages and supervises, schedule and organize daily laboratory and EM activities for microbiologists and technicians. Oversee and engage with the site environmental monitoring (EM) program including developing and maintaining sampling schedules in accordance with procedures, performing sampling of rooms, equipment, and personnel, and performing EM sample management from incubation through isolate ID and completion of EM documentation. Evaluate EM results for trends that may indicate declining microbiological control of the GMP production environment. Complete or oversee the completion of EM quarterly trend reports. Oversee and engage with sterile gowning and gowning validation program at NJ5. Leads by example by maintaining gowning validation and other qualifications as necessary to enter ISO 7 production areas and ISO 5 enclosures for the purpose of performing EM and evaluating aseptic practices. Oversee and engage with the qualification of laboratory equipment at NJ5, specifically, but not limited to microbiology testing and EM equipment. Ensure that equipment is always maintained in a compliant manner. Manage, lead and participate as a subject matter expert with development, testing, deployment and training for EM, gowning, analyst qualification, and cleaning process workflows in Laboratory Information Management System (LIMS). Manage and lead microbiology, sterility assurance and other departmental investigations, including out of specification results associated with sterility or media fill failures, determining root cause, and providing expert guidance on required corrective actions. Review relevant trends (e.g., environmental monitoring, cleaning, sanitization, etc.) to initiate corrective and preventive actions and/or for continuous process improvement. Manage finished product release testing such as sterility, endotoxin, and particulate matter. Perform as required As applicable to support investigations, the ability to perform precise production visual inspection or laboratory appearance testing of finished product requiring 20/20 vision and accurate color differentiation (with or without reasonable accommodation) to assess product quality by evaluating color, clarity and absence of visible particulates for the drug prod