Shrushty Govani

Detail-driven Scientist I with 4+ years of experience delivering audit-ready molecular bioanalytical data for cell and gene therapy programs in a GLP/GCLP-regulated environment. Proven track record across six-plus GLP-regulated AAV and cell/gene therapy studies, executing high-throughput automated workflows (600-800+ samples per study via KingFisher Flex and QIAcube HT) and validated qPCR, RT-qPCR, and ddPCR assays that have consistently supported successful regulatory audits. Adept at 21 CFR Part 58 method validation (LOD/LOQ, accuracy, precision), root-cause troubleshooting, and translating complex bioanalytical data into clear, actionable results.

A trusted cross-functional partner to Study Directors, QA, and CROs, known for combining strong technical rigor with dependable, on-schedule delivery.

Scientist I - Pharmaron - Exton, PA

(2023-01)

• Performed automated nucleic acid extraction and independently executed high-throughput automated workflows, processing 600+ samples per GLP/GCLP study and 800+ samples per R&D study via KingFisher Flex and QIAcube HT for streamlined DNA/RNA extraction and downstream qPCR/RT-qPCR analysis, including NGS-ready sample preparation
• Performed method development, optimization, and validation (LOD/LOQ, accuracy, precision, reference standard) of molecular assays (qPCR, RT-qPCR, ddPCR) for bioanalytical studies, using matrix-spiking protocols to validate molecular biomarkers and target gene expression, ensuring 21 CFR Part 58 compliance across six-plus GLP-regulated AAV and cell-gene therapy studies
• Performed complex data generation, analysis, and validation (LOD/LOQ) across diverse biological matrices using QuantStudio 7 Pro and Bio-Rad QX Manager, applying 96-well plate-mapping, micro-pipetting, and serial dilution discipline directly transferable to bioanalytical assays (MSD, ELISA)
• Executed qPCR and RT-qPCR sample analysis on QuantStudio 7 Pro across diverse biological matrices, performing sample preparation, data generation, analysis, and review to ensure high data quality and reproducibility
• Performed vector copy number (VCN) quantification via qPCR using QIAcube HT-extracted DNA, delivering accurate VCN data for GLP-regulated viral shedding studies
• Supported translational pipelines by executing ex vivo tissue processing and molecular analysis of human gene ALU-based qPCR biodistribution studies in mouse matrix under strict GLP compliance
• Conducted ddPCR method qualification on Bio-Rad QX platforms (QX Manager) across diverse biological matrices
• Conducted root cause analysis and complex troubleshooting for assay deviations, supporting project plans, schedules, and cross-functional coordination on bioanalytical studies to ensure timely delivery of quality data
• Authored and reviewed SOPs, protocols, and technical reports to FDA/ICH standards supporting IND-enabling cell and gene therapy programs, with regulatory documentation supporting successful audit outcomes
• Trained and onboarded new team members while supporting multiple concurrent GLP and R&D studies; collaborated with Study Directors on assay improvements and supported QA during audits
• Maintained chain of custody and full sample traceability via LIMS (STARLIMS), ensuring regulatory compliance and smooth audit processes across all studies
• Measured nucleic acid concentrations with QIAxpert and CLARIOstar instruments, ensuring accurate sample quality for reliable cDNA synthesis, qPCR, and RT-qPCR assays
• Coordinated routine instrument maintenance and vendor servicing to minimize downtime and ensure compliance
• Coordinated laboratory inventory through quarterly cycle counts and reagent/consumable ordering via NetSuite, working with the procurement team to maintain stock levels and uninterrupted study operations

Associate Scientist - Pharmaron - Exton, PA

(2022-06 - 2023-01)

• Conducted RNA and DNA extractions and supported qPCR/ddPCR workflows for hundreds of samples, ensuring on-time data delivery for multiple studies
• Maintained accurate documentation and ensured compliance with 21 CFR Part 58 GLP and GCLP standards, preserving sample integrity and traceability across a project, contributing to a successful audit
• Assisted in executing and troubleshooting molecular assays for bioanalytical studies, including method optimization and inhibition testing with TaqMan probe assays, enabling study timelines to stay on schedule
• Coordinated sample preparation workflows for RNA and DNA extractions, qPCR, and ddPCR, delivering on-time data for multiple nonclinical science studies

Student Research Assistant - Texas Tech University Health Sciences Center - Lubbock, TX

(2021-10 - 2022-04)

• Investigated synergistic drug effects on OVCAR-3 and SK-OV-3 ovarian cancer cell lines using SDS-PAGE, revealing a significant increase in apoptosis markers when drugs were combined
• Maintained and treated OVCAR-3 and SK-OV-3 cell lines under R&D conditions, performed routine passaging and dosing studies, and ensured cell viability remained consistently high across experiments
• Performed protein extraction with RIPA buffer and conducted Western blot analysis using chemiluminescent detection, confirming up-regulation of cleaved caspase-3 in drug-treated samples
• Designed and executed experiments to assess drug efficacy and cellular response, resulting in identification of the most effective drug combinations

Genetic Engineering Intern - Upstream Manufacturing - Zydus Cadila Healthcare - Ahmedabad, India

(2021-01 - 2021-04)

• Assisted with monoclonal antibody production in CHO cell culture systems by following GMP protocols, supporting smooth lab operations and timely batch processing
• Performed cell culture operations, including inoculation, routine monitoring, and cell counting with an automated cell counter, ensuring consistent cell viability and supporting timely progression of antibody production
• Assisted in bioreactor operations across 10 L-5000 L scales, calibrating sensors and executing cleaning protocols that reduced equipment downtime by one shift

M.S. - Biotechnology - Texas Tech University Health Sciences Center, Graduate School of Biomedical Sciences (2023-05)

B.Tech - Genetic Engineering - SRM Institute of Science and Technology (2021-05)