B Raja Rajeshwar

• As the Lab-Incharge, responsible for providing round the clock support to the other Group leaders, Sr. analysts and analysts to execute the projects within stipulated timeline.
• Handling a team of 8-10 members in routine lab operations with 4 LC-MS/MS.
• Coordinating with different clients and management for the project updates.
• Guiding the internal team in Method developments and Method Validations for Regular Nitrosamines, Product based and Process related nitrosamines.
• Involving in the E&L studies performed on LC-MS/MS.
• Guidance to QA team for Data review.
• Operation, maintenance and coordinating with the Service engineers for the proper functioning of LC-MS/MS Systems.
• Preparing, Updating the SOP’s, Method Validation Reports, Method validation protocols, Feasibility and verification reports, MDR’s etc.
• Troubleshooting LC-MS/MS instrumentation and evaluating the data analysed.
• Providing training to juniors on method developments, validations and documentation activities.

• Handling a team of 7-8 members in routine lab operations with 1-2 LC-MS/MS.

• Project execution, Data compilation and training juniors.

• Guidance to quality control team for data review and report preparations.

• Post run data analysis, review of reports, providing support documents prior to regulatory submissions.

• Developing the method for various molecules and performing validation.

Sr. Scientist

• Closely coordinating with the instrument engineers, Clinical research and BSDM team.

• Preparing and Updating the SOP's, reports, Method validation protocols etc.

• Troubleshoot/ maintain instrumentation and evaluating the data analysed.

• Planning of calibrations, schedule PMs of critical instruments.

Scientist

• Operation, calibration and maintenance of LC-MS/MS Systems.

• Preparing bio analytical samples using different extraction techniques (like Liquid Liquid extraction, Protein precipitation and Solid phase extraction) for injection into LC-MS/MS.

• Developing Bio-Analytical methods on different Samples like rat plasma, dog plasma, Human plasma and Serum samples.

• Developed the method for various molecules.

• Checking Purity profile of intermediates and API molecules of In-House and External samples.

• Performing reaction monitoringfor API and intermediates on UPLC and HPLC.

• Troubleshooting HPLC and UPLC.

• In Analytical R&D develop the method for various molecules on HPLC with various detectors.

• Performing the Forced Degradation Studies and Stability studies sample Analysis.

• Preparation of STP's and reports.

• Calibrating the HPLC instruments.

• Mobile phase, Reagents and Sample preparation for HPLC and LC-MS/MS.

• Calibrating the instruments like: HPLC, Micro Pipettes & Multipipette (Eppendorf and thermo), Micro Balance (Mettler Toledo), Analytical Balance (Mettler Toledo), Centrifuge (Eppendorf), pH Meter (Mettler toledo) as per Standard operating procedures.