Principal Scientist/SME for Rapid Microbiology

The Principal Scientist / SME for Rapid Microbiology is responsible for the end-to-end implementation of the ScanRDI for rapid sterility testing. This role leads instrument installation, setup, qualification (IQ/OQ/PQ), method development, validation, and lifecycle management in a regulated environment.

The SME serves as the technical authority for rapid microbiological methods and ensures compliance with global regulatory expectations, including guidance from the FDA and pharmacopeial requirements such as USP <71> Sterility Tests and USP <1223> Validation of Alternative Microbiological Methods. Key Responsibilities
1. Instrument Installation & Setup

• Lead installation and commissioning of ScanRDI systems in collaboration with vendor
• Ensure proper integration with laboratory infrastructure (LIMS, data systems, barcode systems)
• Establish instrument configuration, user access, and data integrity controls (ALCOA+ principles)
• Develop and approve system SOPs for operation, maintenance, and troubleshooting

2. Qualification (IQ/OQ/PQ)

• Author and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
• Define acceptance criteria aligned with intended use (sterility testing, environmental monitoring, etc.)
• Coordinate calibration and preventive maintenance programs
• Ensure traceability of qualification activities for audit/inspection readiness

3. Method Development

• Design and optimize rapid sterility testing methods using ScanRDI, including:
  • Sample preparation and membrane filtration
  • Staining optimization and reagent compatibility
  • Interference and background fluorescence assessment
• Evaluate product-specific impacts (e.g., preservatives, turbidity, autofluorescence)
• Develop recovery strategies for low-level and stressed organisms

4. Method Validation

• Lead validation studies in accordance with USP <1223>
• Execute and document:
  • Accuracy / equivalence to compendial methods
  • Limit of detection (LOD)
  • Specificity (organism panel)
  • Precision and robustness
• Develop statistical justifications and validation reports suitable for regulatory submission and inspection

Required Qualifications

• PhD or MS in Microbiology, Biology, or related field (or equivalent experience)
• 8+ years of experience in pharmaceutical microbiology or sterile manufacturing
• Direct experience with rapid microbiological methods (ScanRDI strongly preferred)
• Demonstrated experience in aseptic processing and sterility testing

Key Competencies

• Deep technical expertise in microbiology and rapid detection technologies
• Strong understanding of GMP and regulatory expectations
• Ability to translate scientific data into regulatory-defensible conclusions
• Excellent problem-solving and troubleshooting skills
• Strong communication skills for cross-functional and regulatory interactions

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