Mahima Thakkar

Surface Plasmon Resonance:

• I have experience working with Surface Plasmon Resonance using Biacore T200 and 8K Cytiva systems.
• Conducted method qualifications for various techniques, ensuring accurate and reliable performances.

Biosimilarity Studies for Large Molecules:

• Conducted comprehensive biosimilarity studies for large molecules using SPR and cell-based assays, ensuring compliance with regulatory standards.
• Performed detailed sample analysis to assess binding interactions and compare the biological activity of reference and test products.
• Developed and optimized analytical methods to enhance the reliability and reproducibility of results.

Quality Management Systems (QMS) Implementation:

• Implemented QMS for multiple molecules, ensuring compliance with regulatory standards, and enhancing overall product quality.
• Developed and refined assurance protocols and documentation to support continuous improvement.

Cell-Based Assay:

• Conducted various cell-based methods, including anti-proliferation assays and Antibody-Dependent Cellular Cytotoxicity (ADCC).
• Designed and optimized experimental protocols to evaluate cellular responses and efficacy of therapeutic drugs.

Non-cell-based assays:

• Designed and executed a range of ELISA assays for large molecules, ensuring precise quantification, and robust performance.

Electronic Lab Notebook (eLN) Implementation:

• Utilized electronic lab notebook (eLN) systems to streamline data management and documentation processes.

• Gained hands-on experience in a QC-GLP laboratory, performing routine and specialized testing of pharmaceutical products under Good Laboratory Practice (GLP) standards.
• Performed performance verification and calibration of the analytical balance and HPLC to ensure accuracy and compliance with regulatory requirements.
• Learned about documentation of test results, equipment calibration, and deviations in compliance with GLP and quality assurance protocols.

• I received hands-on training in phlebotomy techniques, biochemical assays, sample preparation and processing, data handling, record keeping, and ensuring compliance with laboratory safety protocols.