Sudha R Kumar

WORK HISTORY

EDUCATION

SKILLS

ABOUT SUDHA R KUMAR

I am an accomplished molecular biologist with over a decade’s experience in genomics and proteomics, and 6+ years of diagnostic assay development, specializing in CLIA/IVD product innovation. I have developed and validated cutting-edge molecular assays, including RNA-Seq and proteomic biomarker assays, in hematologic malignancies and autoimmune diseases. I\'m experienced in Clinical Trial operations for biomarker discovery, including providing CRO services, biomarker validations, managing internal study operations and data transfer, and reviewing study documentation. My strengths include streamlined product development following Design Control and PDP methods implementation, ensuring transfer readiness of high-impact, regulatory-compliant assays while optimizing lab workflows and resource use.My talents lie in driving collaborative innovation, problem-solving, and operational efficiency. I have a deep technical expertise in next-generation sequencing, hybrid capture NGS, PCR, and statistical tools such as JMP, which I have leveraged to enhance project outcomes and reduce timelines. I excel in leading multidisciplinary teams, mentoring talent, and managing project budgets to achieve lean product development. My ability to identify and mitigate risks early in the development process ensures timely execution and high-quality outcomes.At the core of my work is a commitment to improving health outcomes by developing robust, scalable tools that address unmet medical needs. I value teamwork, accountability, and continuous improvement, believing that collaborative, innovative environments are essential to advancing meaningful breakthroughs in healthcare. I am driven by the opportunity to contribute to transformative life sciences technologies that have the potential to positively impact patient lives.Skills: Molecular Biology, Genomics, Proteomics, NGS/WGS/Target Capture Sequencing/ RNASeq/AmpliSeq, Lab Automation, Illumina sequencing (MiSeq/ HiSeq/ NovaSeq/ NextSeq PCR, RT-PCR, qPCR, Capillary Electrophoresis, ELISA/ ELFA, Flow Cytometry, DNA/RNA Extraction, Nucleic acid extraction and quantification, Biorepository, Inventory management, GMP/GCP/GDP/ICH compliance, FDA IVD Design Control, CLSI study design, CAP/CLIA LDT, Assay Validation, Statistical Data Analysis, QMS Compliance, Clinical Trials Management, SmartSheet, IP portfolio management, Project Management, Budget preparation, Process improvement, Literature Review, MS Office Suite, Troubleshooting, Strategic Planning