Microbiologist III

Empower Pharmacy•Houston, TX

About The Position

The Microbiologist III 503A is a senior technical contributor supporting product quality, patient safety, and microbiological control within Empower’s 503A compounding operations. The role independently performs and reviews complex testing, leads laboratory and contamination investigations, and owns assigned microbiology projects through completion. It provides technical guidance to Microbiologists I and II, strengthens environmental monitoring and contamination control practices, and translates laboratory trends into actionable recommendations. In collaboration with Quality, Production, Engineering, and Validation, the Microbiologist III resolves complex issues and supports scientifically sound quality decisions. The role may also support 503B activities as assigned under applicable site procedures and requirements.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific discipline.
At least five years of progressively responsible microbiology laboratory experience in pharmaceutical, biotechnology, compounding, or a comparably regulated environment.
Direct experience with environmental monitoring, aseptic operations, microbiological investigations, and controlled laboratory documentation.
Demonstrated experience leading complex investigations, reviewing laboratory data, writing or revising procedures, and implementing corrective and preventive actions.
Experience training or mentoring laboratory personnel and coordinating technical projects.
Advanced knowledge of microbiological testing, environmental monitoring, aseptic processing, contamination control, and quality requirements applicable to assigned compounding and laboratory activities.
Ability to interpret complex microbiological data, distinguish laboratory error from process-related contamination, assess risk, and develop scientifically defensible investigation conclusions and corrective actions.
Proficiency in laboratory documentation review, technical writing, trend analysis, method troubleshooting, data integrity practices, and appropriate use of digital laboratory and quality systems.
Ability to lead technical projects, mentor colleagues, influence cross-functional decisions, and communicate microbiological risks to technical and nontechnical audiences.
Strong judgment and organization, with the ability to manage competing priorities independently and escalate issues requiring management or Quality authorization.

Nice To Haves

Experience in sterile compounding or sterile pharmaceutical operations.
Experience with method suitability or validation, contamination control improvements, and audit or inspection support.
Experience applying relevant USP requirements and using laboratory information or electronic quality management systems.

Responsibilities

Independently perform and troubleshoot microbiological testing, environmental monitoring, growth promotion, and sample analysis; review laboratory records and results for scientific accuracy, completeness, data integrity, and compliance with approved procedures within delegated authority.
Coordinate testing priorities, sample tracking, equipment readiness, media controls, inventory, and calibration activities; resolve technical obstacles, communicate turnaround-time risks, and escalate resource or quality concerns.
Lead complex microbiological deviations, environmental excursions, out-of-specification and out-of-trend investigations, and contamination events; define investigation plans, assess evidence, identify root causes, and document scientifically supported conclusions.
Evaluate potential product and process impact with Quality and promptly escalate patient safety concerns.
Develop corrective and preventive actions with owners, completion dates, and effectiveness criteria; track actions to closure, verify controls address root causes, and identify recurring issues requiring broader remediation.
Provide technical support for environmental monitoring plans, sampling practices, recovery patterns, and contamination prevention; analyze trends and recommend justified changes to monitoring, cleaning, disinfection, gowning, and aseptic practices through approved change controls.
Lead assigned method suitability, verification, validation, or transfer activities; draft protocols, evaluate acceptance criteria and results, prepare reports for approval, troubleshoot recurring method or equipment issues, and coordinate implementation with Quality and Validation.
Train and mentor Microbiologists I and II in laboratory methods, aseptic technique, documentation, investigations, and troubleshooting; assess proficiency within assigned authority and provide coaching.
Lead microbiology workstreams for process changes, new equipment, facility improvements, and operational expansion; evaluate microbiological risks, define technical deliverables, and coordinate with Quality Assurance, Production, Engineering, and Validation.