Analytical Scientist

We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a 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.

Roles & Responsibilities

• 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.

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• 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.

BehavioralSkills

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