Senior Research Scientist-Bioanalytical DMPK

Role & responsibilities

Roles and Responsibilities

• Independently design, develop, validate, and troubleshoot bioanalytical methods for small and large molecules using LC-MS/MS and HPLC under GLP and non-GLP environments.
• Thorough understanding of bioanalytical method validation and sample analysis in biological matrices.
• Ability to lead junior team members, manage multiple projects, and interact with clients/regulatory bodies.
• Ensure efficient utilization of instruments and laboratory resources.
• Perform advanced operation, calibration, troubleshooting, and maintenance of LC-MS/MS, HPLC, and allied analytical equipment.
• Knowledge of international bioanalytical regulatory guidelines (USFDA, EMA, MHRA, ICH M10.
• Ensure strict adherence to GLP/GCP guidelines and maintain regulatory compliance in all bioanalytical operations.
• Prepare and review SOPs, validation protocols, study plans, and technical reports for regulatory submissions.
• Conduct literature reviews and contribute to the design of novel bioanalytical approaches.
• Support in writing scientific publications, regulatory submissions, and technical presentations.
• Excellent problem-solving, analytical thinking, communication, and leadership skills
• Strong knowledge of IQ/OQ of the instrument.