Senior Research Scientist-Bioanalytical DMPK
3 days ago
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.
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