Analytical Scientist

Job Summary

• 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 develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples.
• 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 evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process.
• You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements.
• You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment.
• 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.
• You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions.
• You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. 

Educational qualification:

• Have work experience on Process scale up of Active Pharmaceutical Ingredients.
• Experience in Process Optimization (Manufacturing)
• 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.

Behavioral

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams. 

About the Department

Integrated Product Development Organisation

Benefits Offered