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. Working 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. The position leads complex microbiological deviations, environmental excursions, out-of-specification and out-of-trend investigations, and contamination events. It evaluates potential product and process impact with Quality, develops and tracks corrective and preventive actions, and recommends justified improvements to monitoring and contamination-control practices through approved change controls. The role also leads assigned method suitability, verification, validation, or transfer activities; trains and mentors junior microbiologists; and leads microbiology workstreams for process changes, new equipment, facility improvements, and operational expansion. The employee is required to talk and hear. The position often requires remaining stationary for a significant amount of the workday and frequently using hands and fingers to handle or feel in order to access, input, and retrieve information using a computer and other office productivity devices. Employees regularly move about the office and corporate campus and are regularly required to stand, walk, reach, climb or balance, and stoop, kneel, crouch, or crawl.

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, and data integrity practices, including 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; 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 laboratory and operational 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 and verify that controls address root causes.
Serve as a technical resource for environmental monitoring plans, sampling practices, recovery patterns, and contamination prevention.
Analyze environmental monitoring trends by location, organism, personnel, and process, as applicable.
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, and 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 and coordinate technical deliverables with Quality Assurance, Production, Engineering, and Validation.
Support 503B activities as assigned under applicable site procedures and requirements.