VenuGopal Namburi

Leading molecular cancer diagnostics assay design and development for breast, lung, and colorectal cancers. Focused on NGS variant analysis and bioinformatics data analysis in oncology. Experience in developing biological assays and utilizing various NGS platforms for clinical genomics.

Developed molecular diagnostic assays using technologies such as Q Real-time PCR and RT-PCR. Focused on NGS variant analysis and validated SARS-COVID-Q RT-PCR assays in clinical samples.

Handled sample processing and stability validation for diagnostic testing using PCR and sequencing analysis workflows. Worked on core-genomics of cancer diagnostics and generated diagnostic reports for various cancers.

Executed molecular diagnostic testing for clinical samples and developed novel microfluidic devices for circulating tumor cells. Collaborated with hospitals for real-time clinical oncology applications.

Focused on computational and genomic approaches for cancer target genes and in-silico drug design tools for drug molecule identification.

Conducted research on breast cancer molecular therapeutics using human cell lines and gene knock-out approaches.

Investigated molecular mechanisms of cancer progression related to toxic metals and established MT proteins as diagnostic markers.

Compiled regulatory affairs compliance documents for various medical device companies, including Safe Ortho systems UK and Dental Medical devices UK. Reviewed USFDA 510(k) and PMA submissions, and updated technical documents from MDD to MDR.

Developed and submitted comprehensive technical documents for regulatory compliance in EU, USFDA, and CDSCO markets, achieving a 100% approval rate and accelerating product launch timelines by 20%. Authored and submitted regulatory compliance documentation that is now referenced by 5 internal teams, streamlining future submissions and enhancing overall compliance efficiency.

Developed Microfluidic Lab-On-Chip (LOC) IVD for tumor cell isolation and enrichment, successfully achieving design development, validation, and regulatory compliance approvals for USFDA and EU. Managed molecular diagnostic assay device design validations in the area of Cancer Biology, including Human Breast Cancer, Lung Cancer, and Colorectal Cancers.

Worked in the Drug Development Research laboratory with a focus on Computational Biology (Genomics). Gained experience in bioinformatics and data analysis relevant to drug discovery.

Held a senior scientist position, contributing to various biotechnology projects. Applied scientific expertise in a corporate research environment.

Ph.D. in BioSCIENCES with a focus on Toxicological Biochemistry, emphasizing research in molecular diagnostics and cancer therapeutics.

M.Sc. in BioSciences, providing a strong foundation in biological sciences and research methodologies.

B.Sc. in Biosciences, covering essential topics in biology and preparing for advanced studies in the field.

Completed Master of Science degree at Osmania University, focusing on advanced scientific studies. Gained comprehensive knowledge in the chosen field of study.

Completed a Post Graduate Diploma in Clinical Data Management at Biomed Informatics, Medwin Hospitals. Acquired specialized skills in managing clinical data for healthcare and research purposes.