Anaylysts I / II, Senior Analyst I, II

Job Description

The Bioanalytical Analyst and Senior Analyst will support bioanalytical studies in the clinical research domain, focusing on bioanalytical method development, validation, and sample analysis. The candidates will contribute to the execution of bioanalytical projects in compliance with GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and applicable regulatory requirements. Senior Analysts will have more supervisory and project leadership responsibilities. Key Responsibilities: Analyst I/II (3-5 Years of Experience) Bioanalytical Method Development: Assist in developing and optimizing bioanalytical methods, including LC-MS/MS, HPLC, and other analytical techniques. Sample Preparation: Conduct bioanalytical sample preparation, including extraction techniques such as protein precipitation, liquid-liquid extraction, and solid-phase extraction. Method Validation: Assist in bioanalytical method validation following regulatory guidelines (FDA, EMA) for clinical trials. Sample Analysis: Perform bioanalysis of clinical samples such as plasma, serum, urine, etc., ensuring accuracy, precision, and reliability of results. Documentation: Maintain accurate and complete documentation, including lab notebooks, SOPs, protocols, and reports. Compliance: Follow Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) to ensure data integrity. Data Analysis: Process raw data and generate reports for study documentation and regulatory submission. Equipment Maintenance: Operate and maintain laboratory equipment, ensuring proper calibration and troubleshooting as necessary. Senior Analyst I/II (5-8 Years of Experience) In addition to the responsibilities mentioned for Analyst I/II: Project Management: Lead and manage bioanalytical projects, ensuring timely and accurate delivery of results. Supervision: Mentor junior analysts and provide technical guidance to ensure best practices in bioanalytical processes. Regulatory Compliance: Ensure all bioanalytical activities are compliant with regulatory standards (FDA, EMA, etc.) and maintain audit readiness. Client Interaction: Collaborate with sponsors, clients, and cross-functional teams to meet project goals and expectations. Method Troubleshooting: Troubleshoot bioanalytical methods and equipment issues, providing solutions to improve performance. Reporting & Review: Review data analysis reports generated by junior team members, ensuring accuracy and regulatory compliance. Quality Control: Oversee and implement quality control measures for all bioanalytical processes, including internal audits.