Microbiologist

Job Summary

Under the leadership of the Director of Quality, the Senior Microbiologist is responsible for leading and performing microbiological testing, method qualification and validation activities, environmental monitoring oversight, and microbiological investigations in support of sterile pharmaceutical manufacturing operations. This position serves as a subject matter expert (SME) for microbiology-related processes and provides technical guidance to Quality Control personnel.

The Senior Microbiologist ensures all testing activities comply with current Good Manufacturing Practices (cGMP), USP requirements, FDA regulations, and company procedures. The role requires advanced technical expertise, strong analytical and problem-solving skills, and the ability to independently manage complex projects and investigations while supporting continuous improvement initiatives within the Quality Control Laboratory.

Core Responsibilities

• Perform and oversee microbiological testing including:
• USP <71> Sterility Testing
• Bacterial Endotoxin Testing (BET) using kinetic and chromogenic methods
• Bioburden testing
• Microbial identification
• Growth promotion testing
• Water system monitoring and testing, as applicable.
• Serve as the microbiology subject matter expert for laboratory operations, product release testing, investigations, and regulatory inspections.
• Lead method qualification, validation, transfer, verification, and lifecycle management activities for microbiological test methods.
• Review and approve laboratory data, test results, protocols, reports, and associated documentation.
• Lead laboratory investigations related to out-of-specification (OOS), out-of-trend (OOT), environmental monitoring excursions, contamination events, deviations, and non-conformances.
• Conduct root cause analyses and develop effective corrective and preventive actions (CAPA).
• Provide technical support for aseptic processing operations, contamination control strategies, and cleanroom environmental monitoring programs.
• Serve as a backup and technical lead for viable and non-viable environmental monitoring activities.
• Evaluate and trend microbiological data to identify adverse trends and recommend improvements.
• Author, review, and revise SOPs, protocols, validation documents, risk assessments, technical reports, and laboratory procedures.
• Support internal audits, customer audits, and regulatory inspections by preparing documentation and presenting microbiological data.
• Manage laboratory equipment qualification, calibration, maintenance, and lifecycle activities.
• Ensure laboratory supplies, media, standards, and reagents are properly maintained and available.
• Mentor and train microbiology personnel on laboratory techniques, procedures, data integrity, and compliance requirements.
• Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational excellence.
• Maintain a clean, safe, and inspection-ready laboratory environment.
• Comply with all company policies, site procedures, FDA regulations, USP requirements, and applicable cGMP standards.

Qualifications & Requirements

Education

• Bachelor's degree in Microbiology, Biology, Molecular Biology, or related Life Sciences field required.
• Master's degree preferred.

Experience

• Minimum 7–10 years of progressive microbiology experience within a cGMP/FDA-regulated pharmaceutical, biotechnology, medical device, or compounding environment.
• Minimum 3 years of direct experience performing USP <71> sterility, USP<85> Endotoxin, Bioburden testing and microbiological method validation activities.
• Experience leading microbiological investigations and contamination control initiatives.
• Experience supporting regulatory audits and inspections preferred.

Technical Knowledge

• Advanced knowledge of:
• USP <71> Sterility Testing
• USP <85> Bacterial Endotoxin Testing
• USP <61>/<62> Microbial Enumeration and Specified Organisms
• Environmental Monitoring Programs
• Cleanroom microbiology
• Aseptic processing principles
• Laboratory investigations
• Data trending and statistical analysis.
• Strong understanding of FDA regulations, USP requirements, cGMP standards, and data integrity principles.
• Proficiency with laboratory instrumentation, LIMS, electronic quality systems, and Microsoft Office applications.

Competencies

• Strong leadership and mentoring capabilities.
• Exceptional written and verbal communication skills.
• Demonstrated ability to manage multiple priorities and projects independently.
• Strong analytical, troubleshooting, and root cause investigation skills.
• Ability to identify process improvements and implement effective solutions.
• Results-oriented with a commitment to quality, compliance, and continuous improvement.

Position Type

• On-Site

Travel

• Up to 5%