Scientific Support Specialist – Endotoxin Detection Systems & Microbiology

Overview

Provide expert scientific and technical support for Lonza's endotoxin testing portfolio, including reagents, consumables, software and instrumentation, acting as subject matter expert in microbiology, bacterial endotoxins and endotoxin testing methodologies.

What you'll do

• Provide advanced scientific support for endotoxin testing products, reagents, consumables, and instrumentation.
• Support customers using Kinetic Chromogenic LAL assays, Gel Clot assays, Turbidimetric assays, Recombinant Factor C (where applicable), and endotoxin testing software and data management solutions.
• Troubleshoot complex assay performance, contamination, inhibition/enhancement, and validation issues.
• Interpret customer-generated data and recommend scientifically sound corrective actions.
• Support product investigations, complaint handling, and root cause analyses.
• Act as scientific expert for the Nebula® Reader and PyroTec™ PRO System.
• Support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
• Assist customers with instrument configuration, method setup, software workflows, data analysis, and regulatory compliance requirements.
• Collaborate with Field Service Engineers on instrument-related investigations.
• Provide expert guidance on Gram-negative bacteria and endotoxin biology, lipopolysaccharides (LPS), sources of endotoxin contamination, water systems and environmental monitoring, pharmaceutical microbiology, bioprocess contamination control, and sterility assurance concepts.
• Support microbiological risk assessments and contamination investigations.
• Maintain knowledge of applicable regulations and guidance including USP, EP 2.6.14, JP bacterial endotoxin testing requirements, FDA guidance documents, GMP requirements, and Annex 1 contamination control principles.
• Support customer audits and scientific documentation requests.
• Assist with method suitability and validation studies.
• Deliver scientific training programs to customers and internal teams.
• Develop application notes, troubleshooting guides, FAQs, and technical presentations.
• Support workshops, webinars, and scientific conferences.
• Partner with Sales, Marketing, Product Management, R&D, Quality Assurance, Regulatory Affairs and Field Service teams.
• Provide customer insights and market feedback to drive product improvements.

What you'll need

• Expert-level microbiology knowledge (Specialist II): Gram-negative bacterial physiology and LPS structure and function.
• In-depth understanding of bacterial endotoxins and pyrogens.
• Experience in microbial contamination control and environmental monitoring.
• Knowledge of WFI systems, cleanroom microbiology, and aseptic manufacturing.
• Application of pharmaceutical microbiology and sterility assurance principles.
• Familiarity with bacterial growth, metabolism, and biofilms.
• Awareness of cell culture contamination risks and bioprocess microbiology.
• Skill in bioburden testing and microbial identification techniques.
• Expert-level endotoxin testing knowledge (Specialist III): strong command of LAL assay principles and mechanisms.
• Understanding of endotoxin chemistry and biology.
• Performing method suitability and inhibition/enhancement testing.
• Evaluating standard curves and interpreting assay data.
• Troubleshooting assays and calculating endotoxin limits.
• Supporting product validation and method transfer activities.
• Advanced knowledge of alternative pyrogen testing, recombinant technologies, and automation platforms.
• Ability to apply statistical evaluation to assay performance.
• Expert-level instrumentation knowledge: operating and troubleshooting the Nebula® Multimode Reader.
• Managing PyroTec™ PRO System workflow and automation.
• Handling software configuration and data management.
• Understanding of IQ/OQ/PQ qualification protocols and laboratory automation principles.
• Advanced knowledge of optical detection technologies, robotic liquid handling, and LIMS.
• Following data integrity principles in all work.

Nice to have

• PhD in Microbiology, Biochemistry, Pharmaceutical Sciences, or related field.

Details

• Location: Hyderabad, India.
• Office-first role: primarily in the office, with flexibility to work remotely for 40% of time (two days per week).
• Relocation assistance available for eligible candidates and their families, if needed.