Principal Scientist/SME for Rapid Microbiology

• 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

• 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

• 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

• 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

• 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

• 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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