Suvarna Joshi
Scientist Ii @Resilience
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WORK HISTORY
Scientist Ii @Resilience
Led development and optimization of 5+ complex cell-based potency assays and multiparametric flow cytometry panels to characterize biological activity and immune responses for mAbs, recombinant proteins, and AAV/LVV vectors, enabling phase appropriate release testing and regulatory readiness for IND and BLA programs.• Designed, developed, qualified, and validated 15+ ddPCR, dPCR, qPCR, DNA sequencing and RT PCR assays to quantify viral titers, gene and cell therapy products, residual host cell DNA and protein, and plasmid DNA. • Developed and validated 20+ analytical methods across immunoassay, biophysical, and chromatographic platforms including ELISA, MSD, HPLC, Western blotting, gel electrophoresis,CE SDS, cIEF, Octet, DLS, SoloVPE, CD, and endotoxin testing. • Directed end to end analytical method lifecycle management for 50+ methods, including development, qualification, validation, technology transfer, continued performance verification, and trending under GLP, cGMP. Authored and reviewed SOPs, validation protocols, transfer protocols.• Served as analytical SME during technology transfer to QC and external CRO and CDMO partners. • Partnered cross functionally with Process Development, CMC, MS and T, QC, and external collaborators to align analytical control strategies.• Evaluated and implemented high throughput and multiplex assay technologies to improve efficiency, reduce cost per test, and enhance assay robustness.• Mentored and supervised a team of four scientists, overseeing project prioritization, resource allocation, and laboratory operations to ensure timely execution of analytical milestones.• Presented analytical strategies, validation outcomes, and risk assessments to senior management and external stakeholders. • Proficient in Benchling, Empower, Biorad, QuantStudio, SoftMax Pro, GraphPad Prism, PA800 software, and Microsoft Excel, Word, and PowerPoint for data analysis, reporting, and regulatory documentation.
EDUCATION
Maharashtra University of Health Sciences
Doctor of Philosophy - PhD ( Haffkine Institute for Training, Research and Testing), Medical Microbiology
Nagpur University
Master's degree, Microbiology, General
Nagpur University
Bachelor's degree, Microbiology, General
ABOUT SUVARNA JOSHI
Analytical Development leader with a PhD in Cell and Molecular Microbiology and over six years of industry experience leading method lifecycle management for complex biologics and cell and gene therapies across clinical and commercial stages. Expertise in method development, qualification, validation, technology transfer, and continued performance verification in cGMP environments supporting IND and BLA submissions.Strong technical background in cell-based potency assays, ddPCR, qPCR, DNA Sequencing, ELISA, CE SDS, cIEF, Western Blotting, HPLC and biophysical characterization across protein therapeutics and rAAV and LVV platforms. Experienced in authoring validation and transfer protocols, performing statistical trending, resolving deviations and CAPAs, and partnering cross functionally with Process Development, QC, MS and T, Regulatory Affairs, and external partners. Recognized for mentoring scientists and presenting analytical strategies to senior management. Permanent Resident with no sponsorship required.
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