Job Description

The job description is as below:

• Performing Bacterial Endotoxin Tests (BET): Utilizing the Limulus Amebocyte Lysate (LAL) assay, specifically the kinetic turbidimetric or kinetic chromogenic methods, to detect and quantify endotoxins in raw materials, in-process samples, and finished products.
• Operating Kinetic Readers and Software: Operating specialized microplate readers (e.g., Lonza's Nebula readers or Associates of Cape Cod's Pyros Kinetix) that monitor the absorbance or color change over time to determine endotoxin concentrations. This involves using associated software like WinKQCL for data acquisition and analysis.
• Method Development and Validation: Qualifying and validating test methods for different products, which includes determining the Maximum Valid Dilution (MVD) and ensuring the sample pH is within the optimal range (typically pH 6-8).
• Documentation and Compliance: Maintaining rigorous documentation and ensuring all testing procedures adhere to regulatory standards, such as those outlined by the USP and ISO 11737-3:2023, and data integrity requirements like 21 CFR Part 11.
• Troubleshooting: Investigating and resolving assay failures or deviations (e.g., issues with standard curves, invalid controls).

Required Skills and Qualifications

• Education: A Bachelor's or Master's degree in Microbiology, Biotechnology, or a related life science field is typically required.
• Technical Skills: Hands-on experience with aseptic techniques, general microbiology testing (bioburden, sterility), and specific experience with LAL testing methods and kinetic readers.
• Regulatory Knowledge: Understanding of GMP (Good Manufacturing Practices) and regulatory guidelines related to endotoxin testing.
• Attention to Detail: Meticulous attention to detail for accurate sample preparation, testing, and data recording, as results directly impact product safety and batch release.

For Further details please call Megha on 9377677857 or you can mail your candidature on megha@postaresume.co.in

Skills Required