Somya Sharma

Analysis and Protocol Optimization:

• Conducted cost-of-goods studies for Library Construction (LC), Target Enrichment (TE), and sequencing processes, evaluating protocol modifications while maintaining gold standard performance.

Data Analysis and Clinical Research:

• Analyzed Illumina sequencing data as part of an early cancer detection study, contributing to efforts aimed at gaining clinical trial approval.
• Designed and implemented analytical methods for various DNA mediums (cfDNA, gDNA, Oligos) to test different SOP modules.
• Performed clinical study protocols with adherence to GLP, GMP, ISO, and QSR requirements, ensuring clear and complete records for FDA product development guidelines.

Product Development and Support:

• Assisted scientists in translating research ideas into product development pipelines for diagnostic assays in early cancer detection.
• Prepared detailed reports and documentation, summarizing experimental results, and presenting outcomes and next steps to supervisors, technical teams, and project teams for LDT, IVD, and FDA approval.

Technical Expertise and Laboratory Techniques:

• Performed genomic DNA fragmentation using Covaris R230 Ultrasonicator, quantified samples using Agilent TapeStation, and conducted manual/automated normalization for library construction.
• Managed target enrichment and loading of libraries onto Illumina Seq X and Seq 6000 sequencers.
• Competent in using Hamilton STAR liquid handlers for DNA preparation, including target enrichment and library normalization.

Quality Management and Compliance:

• Supported and complied with the company's Quality Management System policies and procedures, including writing and updating SOPs, protocols, and reports.

Sample Preparation and Sequencing:

• Knowledgeable in biological sample preparation and extraction techniques for downstream LC-MS analysis.
• Led research evaluation studies to prepare large-DNA sequencing libraries from clinical samples for Next-Generation Sequencing (NGS).
• Developed and implemented computational pipelines and methods for processing and analyzing NGS data.
• Coordinated and executed NGS applications, worked on independent and team research projects, and presented findings to project teams.
• Analyzed and led experiments involving DNA sequencing for mutations, balanced amplicons, and other complex data types, including NGS data.

Sample Processing and Compliance:

• Executed patient sample processing from accessioning to result generation, strictly following CLIA standards.
• Logged records into the Laboratory Information Management System (LIMS), ensuring compliance with HIPAA regulations for data privacy and confidentiality.

Handling and Analysis:

• Managed human urine samples for liquid biopsy, utilizing exosome-based cancer tests to aid in prostate biopsy decisions.
• Conducted filtration of urine samples to isolate exosome-based RNA, proteins, and cell-free DNA, focusing on RT-PCR and qPCR analysis for downstream applications.
• Monitored and addressed any issues related to sample thickness or blood spotting, accurately documenting quantities and observations in LIMS.

Data Management and Quality Control:

• Performed data entry into the FMI Laboratory Information Management System (LIMS), including the assignment of unique computer-generated identification numbers to each sample.
• Evaluated and ensured quality control within the laboratory by conducting standard tests and measurement controls, maintaining compliance with CLIA, OSHA safety, and risk management guidelines.