Microbiologist Lead

Quality Control Microbiology Laboratory — Sterile Pharmaceutical Manufacturing

The Microbiologist Lead is a senior technical position within the QC Microbiology Laboratory, responsible for performing and providing technical leadership for routine and advanced microbiological testing, environmental and utility monitoring, laboratory investigations, qualification and validation activities, data review, and training. The Lead works as a hands-on, bench-level technical resource for lab personnel and provides day-to-day technical guidance under the direction of the Microbiology Supervisor and Quality management.

This role may coordinate daily lab activities and provide technical direction to others but does not replace the Supervisor's personnel-management responsibilities unless specifically delegated.

• Independently perform and provide technical guidance for sterility (USP ), endotoxin/BET (USP ), bioburden (USP ), environmental and utility monitoring, growth promotion, microbial , and Biological Indicator testing
• Perform testing using appropriate aseptic technique and approved procedures
• Handle calculations, data entry, result interpretation, and documentation
• Review lab records and results as authorized
• Identify questionable or atypical results and escalates promptly
• Help evaluate recovered organisms and determine follow-up activities

• Serve as the primary bench-level technical resource for Microbiologists and Technicians
• Provide day-to-day technical guidance on methods, aseptic technique, equipment, and troubleshooting
• Assist the Supervisor with prioritization and coordination of testing and monitoring activities
• Flag delays, capacity issues, testing abnormalities, or compliance concerns to the Supervisor
• Serve as designated technical backup for the Supervisor when assigned
• Help maintain lab supplies, reagents, media, cultures, and equipment
• Coordinate equipment maintenance, calibration, and qualification activities
• Train and mentor Microbiologists and Technicians in approved procedures
• Demonstrate proper aseptic technique, testing practices, and documentation habits
• Support analyst qualification and competency assessments
• Identify training needs and recommend them to the Supervisor
• Promote consistent application of procedures and good documentation practices

• Perform, coordinate, and review environmental monitoring in classified manufacturing areas
• Review and trend viable/nonviable EM results, personnel monitoring, and utility data
• Help identify adverse trends, recurring organisms, and loss of environmental control
• Support EM performance qualification and requalification activities
• Support investigation of EM excursions and atypical recoveries

• Initiate, author, and support microbiology-related investigations, deviations, and nonconformances
• Troubleshoot microbiological methods, equipment, media, reagents, and testing processes
• Support investigations involving sterility, EM, bioburden, endotoxin, water, microbial , and lab errors
• Assist with root cause analysis and CAPA development
• Document conclusions and communicate significant findings to the Supervisor

• Author and/or execute microbiology protocols, studies, and reports as assigned
• Support method development, suitability, verification, qualification, validation, and transfer
• Support qualification of autoclaves, isolators/VHP, EM performance, disinfectants, water systems, and equipment
• Compile, analyze, and summarize data from qualification, validation, and investigation activities
• Author and revise SOPs, test methods, protocols, reports, and technical assessments
• Support internal audits and regulatory inspections as a technical resource
• Ensure activities comply with 21 CFR 210/211, USP microbiology chapters, EU GMP Annex 1, and cGMP/cGLP requirements

• Collaborate with Manufacturing, QA, Validation, Engineering, and Facilities on microbiology matters
• Support manufacturing investigations, process changes, and validation projects
• Participate in continuous improvement projects across…