Position Summary
The Senior Microbiologist serves as a technical leader within the Microbiology laboratory, responsible for advanced microbiological testing, complex troubleshooting, and oversight of laboratory investigations. This role drives scientific rigor and compliance by leading root cause investigations, owning CAPAs, and executing continuous improvement initiatives.
The Senior Microbiologist is a subject matter expert (SME) in Environmental Monitoring (EM), Water for Injection (WFI), and product-related microbiological testing, and plays a key role in mentoring and developing laboratory personnel while supporting cGMP sterile manufacturing operations.
Job Responsibilities
- Technical Expertise & Laboratory Leadership
- Serve as a subject matter expert (SME) for microbiological methods, testing techniques, and equipment.
- Maintain training and provide technical guidance to Microbiologists on all microbiological testing including product and water bioburden, endotoxin testing, TOC and Conductivity, sterility, and organism identification.
- Lead and execute complex microbiological testing, method troubleshooting, and atypical result evaluations.
- Evaluate and improve microbiological methods for robustness, compliance, and efficiency.
- Support method validations, verifications, and transfers.
- Investigations, CAPAs, & Quality Systems
- Lead and own microbiological deviation and laboratory investigations, including thorough root cause analysis.
- Author and drive corrective and preventative actions (CAPA) to completion against defined timelines, ensuring effectiveness and sustainability
- Act as primary microbiology representative in investigations impacting manufacturing, utilities, or product quality
- Execute microbiological change controls for laboratory and manufacturing processes with technical accuracy
- Process Improvement & Continuous Improvement
- Lead process improvement initiatives to enhance laboratory efficiency, compliance, and audit readiness
- Drive risk-based decision making for prioritization
- Mentorship & Team Development
- Provide bench-side mentorship, coaching, and technical training to Microbiologists
- Develop training materials and ensure effective onboarding and ongoing competency development
- Act as a resource for troubleshooting and scientific problem-solving for the team
- Regulatory Inspections & Audit Readiness
- Serve as the primary microbiology representative during regulatory inspections
- Responsible for ensuring inspection readiness
- Maintain effective communication with inspectors
- Drive actions for successful resolution of audit observations or improvements identified.
- This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.
Experience Requirements
- Minimum of 5-8 years of related laboratory experience, academic or otherwise
- Knowledge of aseptic techniques
- Knowledge of cGMP
- Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment
- Demonstrated experience leading investigations, CAPAs, and root cause analysis
- Strong leadership, mentoring, and coaching skills
- Ability to multi-task, work under pressure with time constraints
- Must be flexible and able to adapt to changes in task priority
- Excellent communication skills and ability to work independently to complete tasks
Education Requirements
- Bachelor of Science (BS) Degree in Microbiology, Biology, or related Life Sciences.
