SHALINI SINGH

• Accountable for Method development and validation for process related residual impurity analysis using kit based ELISA and qPCR assays for multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.
• Involved in Method development of cell based potency assay for a TNF alpha inhibitor molecule.
• Involved in Characterization assay development for mRNA vaccine under developmental stage using Microscopy and flow cytometry.
• Accountable for Handling and maintaining the laboratory compliances.
• Documented changes during experiments, noting unexpected issues and arising during research activities and finding probable solutions.
• Trained newly hired employees on processes and procedures relevant to lab tasks at hand.
• Established effective collaborations with external partners to leverage resources and expertise for project success.
• Utilized data-driven insights such as data analysis and trending to refine analytical approach.

• Quality analysis of Viral vaccines (MMR and Varicella) from in process to finished product stage through out the product life cycle including product release and stability analysis while adhering to the timeline to meet company business standards.
• Worked on improving the product quality by implementing standard testing procedures, validating the implemented procedures and addressing identified issues.
• Worked on reviewing and maintaining the GLP compliance which included regular reviews of standard operating and testing procedure, Calibration and qualification of laboratory equipments, documentation control, to ensure alignment with current industry best practices and regulatory requirements.
• Learned the impact of utilizing advanced instrumentation and software technologies like LIMS, SAP and implementation of same in day to day work.
• Collaborated with cross-functional teams to identify areas for improvement, driving continuous quality enhancements.
• Trained newly hired employees on processes and procedures relevant to lab tasks at hand

• Learned the basics of cGMP practices and the role of adherence to compliance.
• Learned the basics of manufacturing procedure for Viral vaccine (rabies and polio vaccine) production and documentation.
• Learned the basic Quality Control analysis of viral vaccine products.
• Learned the role of cross functional departments and collaborative approach to ensure the overall compliance to maintain product quality.

GPA: 73%