Analytical Scientist

• You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples.
• You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods.
• You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities.
• You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development.
• You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department.
• You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed.
• You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour.
• You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency.
• You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions.
• You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results.
• You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy.

• 5 years of experience in analytical method development
• Strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards
• Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques
• Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
• Proven experience in method validation and documentation in compliance with regulatory requirements
• Have work experience on Process scale up of Active Pharmaceutical Ingredients, Experience in Process Optimization (Manufacturing)

Masters in Science/ Organic chemistry