Microbiologist Manager

Position Summary The Microbiology Manager is responsible for leading and overseeing all microbiological operations within Medivant s 503B pharmaceutical outsourcing facilities. This role ensures compliance with FDA regulations, cGMP standards, USP requirements, and internal quality systems while supporting sterile manufacturing through effective environmental control, microbiological testing, contamination prevention, and continuous improvement initiatives. The ideal candidate will provide leadership to the microbiology team, maintain inspection readiness, and collaborate cross-functionally with Quality Assurance, Manufacturing, and Validation teams to ensure product quality and regulatory compliance. Key Responsibilities Provide leadership and oversight for all microbiological programs including Environmental Monitoring (EM), Personnel Monitoring (PM), Sterility Testing, Endotoxin Testing (BET), Bioburden Testing, and Microbial Identification. Supervise, train, mentor, and develop microbiology staff while ensuring adherence to cGMP standards, aseptic practices, and ISO cleanroom requirements. Review, approve, and trend microbiological data including EM/PM results, sterility testing outcomes, and microbial identification reports. Lead investigations related to OOS, OOT, contamination events, and environmental excursions, ensuring timely closure and implementation of CAPAs. Support qualification and validation activities including microbiological methods, disinfectant efficacy studies, sterilization cycles, and cleanroom controls. Partner closely with Quality Assurance and Manufacturing teams to provide microbiological guidance for aseptic processing and contamination control strategies. Serve as Subject Matter Expert (SME) during FDA inspections, customer audits, and regulatory reviews. Ensure laboratory readiness through proper inventory management of media, reagents, consumables, and equipment. Develop, review, and approve SOPs, protocols, validation reports, and technical documentation related to microbiology operations. Maintain training programs to ensure staff competency, compliance awareness, and aseptic qualification standards. Evaluate and implement new technologies, testing methods, and process improvements to enhance quality, efficiency, and compliance. Promote a culture of safety, quality, accountability, and data integrity (ALCOA+ principles).

Qualifications Required:

Bachelor s degree in Microbiology, Biology, or related scientific field. 6-10+ years of pharmaceutical microbiology experience, preferably within sterile manufacturing or 503B outsourcing facilities. Strong knowledge of cGMP regulations and USP chapters including <71>, <61>, <62>, <85>, <1116>, and <797>/<800> as applicable. Proven experience managing microbiology laboratory operations, environmental monitoring programs, sterility assurance, and investigations. Hands-on experience with CAPAs, Change Controls, Deviations, OOS/OOT investigations, and audit readiness. Strong leadership, communication, organizational, and technical writing skills.

Preferred:

Master s degree in Microbiology, Biology, or related scientific field. Experience with electronic Quality Management Systems such as MasterControl, Progen, or similar platforms. Previous experience supporting FDA inspections or regulatory audits in a pharmaceutical environment. Key Competencies Leadership & Team Development Regulatory Compliance & Inspection Readiness Technical Expertise in Microbiology Problem Solving & Root Cause Analysis Data Integrity & Quality Focus Cross-Functional Collaboration Continuous Improvement Mindset Please note that we are not providing H1B visa sponsorship for this role. Candidates will be solely responsible for managing and maintaining their own visa sponsorship status.