Goli Rajasekhar

A highly committed, self-motivated, and detail-oriented professional with extensive experience in LC-MS analysis, data review, and team leadership. Seeking a challenging position as an LC-MS Review and Team Lead in a reputable organization to leverage my expertise in method development, validation, data integrity, and quality compliance, while mentoring team members and ensuring high accuracy in analytical outputs. Dedicated to driving operational excellence, fostering continuous learning, and contributing significantly to the success and growth of the organization.

• Accomplished Research Professional and Effective Team Leader, recognized for a positive approach, strong commitment to work, and quick learning ability.
• Skilled in Time Management and Project Execution, ensuring timely completion of deliverables through strategic planning, effective review processes, and excellent team coordination and support.

• LCMS:
• Agilent UPLC with 6470 & 6495 Mass Spectrometers (Mass Hunter software)
• Waters UPLC TQS Micro (Mass Lynx software)
• Shimadzu 8060 NX and RX with lab solution softwarer
• AB-Sciex-6500+ with Sciex OS Software.
• HPLC:
• Waters HPLC e2495 (Empower 3 software)
• Shimadzu HPLC-2010CHT & 2010ACT (LC Solutions, Empower 3 software)
• GC:
• Agilent 6890 & 7890A (Empower 3 software, Head Space Module)
• Thermo Scientific TRACE 1300 Series (Chromeleon software, Head Space Module)

• Lead and review Genotoxic Impurities (GTIs) and Carryover Studies, ensuring compliance with global regulatory requirements.
• Supervise and review Method Development & Validation activities for GTIs, nitrosamines, and NDSRIs in APIs and finished products using LC-MS/MS and GC-MS/MS.
• Ensure proper instrument calibration, troubleshooting, and performance qualification of LC-MS/MS and GC-MS/MS systems.
• Review Method Development Reports (AMDRs), Method Validation Protocols, and Method Validation Reports (AMVRs) in line with regulatory and internal quality standards.
• Handle and resolve client queries related to method development and validation, ensuring timely and effective communication.
• Provide team leadership, training, and mentoring in GLP practices, compliance, and advanced LC-MS techniques.
• Prepare and review validated Excel calculation sheets and ensure their regulatory compliance.