As a Principal Scientist in the Small Molecule Bioanalytical Laboratory at Syngene International Ltd., your role will involve overseeing studies conducted in the laboratory, performing critical method development and validation programs, and ensuring technical and regulatory compliance of all studies. You will be responsible for working with a collaborative bioanalytical team for analyzing NCEs and Generics using LC-MS/MS, monitoring day-to-day activities in the laboratory, reviewing method development and validation protocols, ensuring regulatory compliance, and maintaining high-quality deliverables within project timelines. Additionally, you will independently manage studies and teams, engage in technical forecasting and troubleshooting, and participate in cross-functional project meetings.

Key Responsibilities:

• Collaborate with a team of analyzing scientists for method development, validation, and sample analysis using LC-MS/MS
• Monitor and guide day-to-day activities in the laboratory including method development, validation, and study sample analysis
• Review method development and validation protocols, study sample analysis protocols, and bioanalytical reports
• Ensure regulatory compliance and technical compliance of programs, adhering to GLP/GCP guidelines
• Manage studies and teams independently, from execution to data analysis and interpretation
• Engage in technical forecasting, troubleshooting, client interactions, and strategic planning
• Work collaboratively across various functions within the laboratory and departments within Syngene
• Oversee performance management and assessment of reporting staff, fostering a culture of excellence and continuous improvement

Qualifications

• Education: Masters or PhD in Pharmaceutical Sciences from a reputed university
• Industry Experience: Direct experience in small molecule bioanalysis with a focus on LC-MS/MS based assays, success in regulatory audits, and experience in GCP/GLP bioanalytical laboratories
• People Leadership Experience: Proven ability in leading, developing, and managing teams
• Exposure And Experience: Experience in a Small Molecule Bioanalytical CRO lab, developing and validating LC-MS/MS methods for large molecules, and hands-on experience with Watson LIMS will be advantageous

Core Competencies:

• Scientific: Creative, innovative, curious, eager to learn, and able to think scientifically
• Technical: Conducts experiments effectively, reports data punctually, troubleshoots logically, and has good organizational and client engagement skills
• Documentation: Records data accurately, pays attention to detail, responds promptly to QC and QA reports, and writes clearly and concisely

Syngene International Ltd. is an equal opportunity employer, providing EEO to all individuals regardless of age, gender, race, religion, disability, or any other characteristic protected by law. Reasonable accommodations will be provided for qualified individuals with disabilities. For more information about Syngene, please visit their website. As a Principal Scientist in the Small Molecule Bioanalytical Laboratory at Syngene International Ltd., your role will involve overseeing studies conducted in the laboratory, performing critical method development and validation programs, and ensuring technical and regulatory compliance of all studies. You will be responsible for working with a collaborative bioanalytical team for analyzing NCEs and Generics using LC-MS/MS, monitoring day-to-day activities in the laboratory, reviewing method development and validation protocols, ensuring regulatory compliance, and maintaining high-quality deliverables within project timelines. Additionally, you will independently manage studies and teams, engage in technical forecasting and troubleshooting, and participate in cross-functional project meetings.

Key Responsibilities:

• Collaborate with a team of analyzing scientists for method development, validation, and sample analysis using LC-MS/MS
• Monitor and guide day-to-day activities in the laboratory including method development, validation, and study sample analysis
• Review method development and validation protocols, study sample analysis protocols, and bioanalytical reports
• Ensure regulatory compliance and technical compliance of programs, adhering to GLP/GCP guidelines
• Manage studies and teams independently, from execution to data analysis and interpretation
• Engage in technical forecasting, troubleshooting, client interactions, and strategic planning
• Work collaboratively across various functions within the laboratory and departments within Syngene
• Oversee performance management and assessment of reporting staff, fostering a culture of excellence and continuous improvement

Qualifications

• Education: Masters or PhD in Pharmaceutical Sciences from a reputed university
• Industry Experience: Direct experience in small molecule bioanalysis with a focus on LC-MS/MS based assays, success in regulatory audits, a