Dr. SHREEPA JAYESH CHAUHAN

Led GMP-compliant analytical and release testing of raw materials, in-process samples, and autologous/allogenic CAR-T drug products, ensuring batch consistency, regulatory compliance, and manufacturing readiness.

• Led development, miniaturization, and optimization of cell-based potency and ELISA assays, including DOE-based robustness studies.
• Successfully transferred qualified methods from Analytical Development to GMP QC operations, including preparation of validation protocols, SOPs, and analyst training.
• Investigated atypical assay results and laboratory deviations, conducting root cause analysis and implementing CAPAs to restore method integrity and prevent recurrence.
• Established, cultured, and banked mammalian cell lines (primary and engineered), executing aseptic technique, cell isolation, transduction, and both manual and automated viability assays.
• Served as Subject Matter Expert (SME), training scientists and lab personnel on immunoassays, instrumentation (flow cytometry, Incucyte, ELISA systems), and automation platforms to enhance team capability. Provided technical guidance and informal oversight to junior scientists and analysts, supporting execution of GMP bioassays and documentation.
• Collaborated with PD, Quality, and Manufacturing teams to support tech transfer, change controls, comparability studies, and continuous improvement initiatives across the product lifecycle.
• Maintained precise documentation in ELN/LIMS, performed data analysis using Graphpad Prism, SoftMax Pro, and JMP, and presented findings to cross-functional team for process improvement.

• Executed cell-based bioassays including cytotoxicity, reporter gene assays, and ELISA to evaluate potency and functional activity of CAR-T products, ADCs, and bispecific biologics.
• Supported assay development, optimization, and bridging studies to enable method transfer from development to GMP laboratories.
• Interacted with internal and external clients to discuss assay performance, troubleshoot issues, and ensure successful project execution in a CDMO environment.
• Assisted with performance qualification of laboratory equipment, supporting regulatory inspection readiness and ensuring assay reliability across projects.
• Effectively managed daily laboratory responsibilities and workflows to meet project schedules and critical deadlines.
• Maintained accurate GxP documentation in ELN systems, supporting regulatory inspection readiness.
• Trained and mentored junior team members in tissue culture, assay execution, and instrument operation.
• Spearheaded initiatives to streamline laboratory workflows, resulting in improved turnaround times for project deliverables.

• Conducted translational research on miRNA-149 and PAF-R signaling in lung cancer using cell-based functional assays.
• Performed molecular biology techniques including DNA/RNA extraction, qRT-PCR, ddPCR exposure, extracellular vesicle analysis, and flow cytometry.
• Designed and executed cytotoxicity, cytokine release, proliferation, and viability assays with statistical analysis using JMP and Minitab.
• Collaborated with faculty and peers to design and execute experiments across various disciplines.
• Analyzed data using statistical software, ensuring accuracy and reliability of results for reports.
• Developed presentations summarizing research findings for academic conferences and departmental meetings.

• Supported patient monitoring, including vital signs, medication adherence, and clinical evaluations, ensuring safe and effective therapy management.
• Provided evidence-based drug information using Micromedex and CIMS to support clinical decision-making.
• Maintained source documentation and ICSR records; monitored and reported ADRs, and medication interactions.
• Prepared and supervised chemotherapy admixtures, ensuring accurate dosing, sterility, and regulatory compliance.
• Collaborated with multidisciplinary healthcare teams to optimize therapy plans and patient outcomes.

• Ensured compliance of drug safety, clinical documentation, and regulatory standards (US FDA, CDSCO).
• Evaluated medication appropriateness, efficacy, and safety, intervened to optimize therapeutic outcomes.
• Oversaw end-to-end medication processes from procurement through dispensing, ensuring GxP compliance.
• Maintained comprehensive documentation and electronic records to support regulatory inspections and QA audits.
• Provided evidence-based clinical support and patient counseling to improve therapeutic outcomes.