Job Summary

Scientific Support Specialist - Endotoxin Detection Systems Microbiology

Location: Hyderabad, India

This is an office-first role. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 40% of your time (two days per week).

The actual location of this job is in Hyderabad, India. Relocation assistance is available for eligible candidates and their families, if needed.

The Scientific Support Specialist provides expert scientific and technical support for Lonzas endotoxin testing portfolio, including reagents, consumables, software solutions, and instrumentation such as the Nebula Multimode Reader and PyroTec PRO Automated Endotoxin Testing System. The role serves as a subject matter expert (SME) in microbiology, bacterial endotoxins, and endotoxin testing methodologies, supporting customers, sales teams, field service engineers, product management, quality, and RD.

The incumbent is responsible for resolving complex scientific inquiries, troubleshooting product performance issues, supporting method development and validation activities, conducting customer training, and ensuring the successful implementation of endotoxin testing solutions in regulated environments.

Responsibilities

- Provide advanced scientific support for endotoxin testing products, reagents, consumables, and instrumentation.

- Support customers utilizing
- Kinetic Chromogenic LAL assays
- Gel Clot assays
- Turbidimetric assays
- Recombinant Factor C (where applicable)
- 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.

Instrument and Software Expertise

- 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
- Regulatory compliance requirements

- Collaborate with Field Service Engineers on instrument-related investigations.

Microbiology Expertise

- 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
- Sterility assurance concepts

- Support microbiological risk assessments and contamination investigations.

Regulatory and Compliance Support

- Maintain knowledge of applicable regulations and guidance including:

- USP
- EP 2.6.14
- JP bacterial endotoxin testing requirements
- FDA guidance documents
- GMP requirements
- Annex 1 contamination control principles

- Support customer audits and scientific documentation requests.
- Assist with method suitability and validation studies.

Customer Training and Education

- Deliver scientific training programs to customers and internal teams.
- Develop application notes, troubleshooting guides, FAQs,



and technical presentations.
- Support workshops, webinars, and scientific conferences. Cross-Functional Collaboration

- Partner with

- Sales
- Marketing
- Product Management
- RD
- Quality Assurance
- Regulatory Affairs
- Field Service teams

Provide customer insights and market feedback to drive product improvements.

What we are looking for

Microbiology Knowledge (Expert Level: Specialist II)

- Expert in Gram-negative bacterial physiology and LPS structure and function.
- Understand bacterial endotoxins and pyrogens in depth.
- Experienced in microbial contamination control and environmental monitoring.
- Knowledgeable in WFI systems, cleanroom microbiology, and aseptic manufacturing.
- Apply pharmaceutical microbiology and sterility assurance principles.
- Familiar with bacterial growth, metabolism, and biofilms.
- Aware of cell culture contamination risks and bioprocess microbiology.
- Skilled in bioburden testing and microbial identification techniques. Endotoxin Testing Knowledge (Expert Level: Specialist III)

- Solid command of LAL assay principles and mechanisms.
- Understand endotoxin chemistry and biology.
- Perform method suitability and inhibition/enhancement testing.
- Evaluate standard curves and interpret assay data.

- Troubleshoot assays and calculate endotoxin limits.
- Support product validation and method transfer activities.
- Advanced knowledge of alternative pyrogen testing, recombinant technologies, and automation platforms.

- Able to apply statistical evaluation to assay performance.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change.

Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Scientific Support Specialist - Endotoxin Detection Sys Microbiology (Hyderabad)
🏢 Lonza
📍 Hyderabad