Kalpana Venkat

Scientist with 10+ years of experience leading interdisciplinary research in cancer biology, stem cell research, functional genomics, and translational oncology. Deep expertise in molecular biology, CRISPR genome engineering, generating stable cell lines using lentiviral, PiggyBac, and minicircle systems, and advancing biomarker discovery through NGS (Long, short, and single-cell). Experienced in mammalian cell culture, CRISPR-based genome engineering, molecular cloning, and genetic analysis.

Proven track record of independently leading research projects, mentoring scientists, authoring SOPs, and translating innovative technologies into robust laboratory workflows. Brings a strong understanding of regulatory-aligned laboratory practices supporting oncology and advanced therapy programs.

Technical Development Principal Scientist - Genentech - CA, USA

(2022-01 - 2025-12)

Genomics lead- Cancer Vaccine and Cell Therapy programs

• Led multidisciplinary genomics research supporting oncology and cell therapy programs.
• Evaluated and deployed emerging sequencing technologies (WES, Bulk RNA Seq workflows), delivering molecular biomarker data to inform patient stratification, neoantigen prediction, and mRNA vaccine safety assessment.
• Developed a unified FFPE- based sequencing workflow consolidating WES and RNA-Seq, significantly reducing turnaround time and cost while maintaining clinical-grade performance.
• Pioneered genomic integrity assessment and QC biomarker frameworks for iPSC-derived cell therapies, including the first-in-program WGS (PacBio Revio) implementation to identify high-risk variants impacting product safety and genomic integrity, serving as a critical QC model for multiple cell therapy donor screens.
• Established and scaled high-throughput scRNA-seq capabilities to enhance deeper resolution of cellular pathways and was recognized with the 'Rising Star' award.
• Served as subject matter expert for genomics technologies, advising PD and Bioinformatics teams on experimental design, platform selection, assay strategy, and data generation approaches.
• Oversaw installation, validation, and optimization of sequencing instrumentation (MiSeq, ONT) and data storage capabilities, qPCR, ddPCR instruments, Bioanalyzer, TapeStation, developed and maintained SOPs, training materials, and best practices for genomics assays and laboratory operations.
• Implemented qPCR array as a potential IPC for iPSC differentiation and expansion stages, as well as drug product screening.
• Collaborated with supply chain and Biosampling teams to ensure appropriate sample handling and processing steps are performed during clinical trials.
• Trained, mentored, and supported research associates, interns, and cross-functional scientists, ensuring consistent technical execution and skill development.
• Managed CROs and external partners, established NDAs, work plans, budgets, and invoices, assay development, transfer, validation, and associated reports, sample analyses, and data transfer from CAP/CLIA certified labs to implement new genomics technologies.
• Actively contribute to external scientific communication through invited talks, publications, and cross-industry collaborations.

Scientist II / Assistant Project Manager / Scientific & Technical Support Specialist - System Biosciences - CA, USA

(2017-01 - 2022-12)

• Managed 300+ RNA Seq projects (over 1000 clinical samples), overseeing experimental design, platform selection, partial library prep, sequencing, troubleshooting, and data analysis and interpretation.
• Operated in a high-throughput, shared-resource environment, balancing multiple concurrent projects and stakeholder priorities.
• Provided hands-on support for RNA isolation, library prep, QC across diverse biological matrices, data analysis, and interpretation.
• Supported customized stable cell line development via viral transduction or transfection of transposon-based DNA vectors.
• Resolved critical technical issues across bioanalytical products, enabling return-to-market and next-generation product launches (3 ELISA kits and Antibody Array kit).
• Trained and mentored junior scientists and global customers; developed technical content, delivered scientific webinars, organized hands-on workshops, conferences, and represented the company at external scientific forums.
• Collaborated cross-functionally with R&D, product development, and marketing teams to align on product strategy.
• Supported technology evaluation, alpha/beta testing, and validation of new genomics products and assays.

Instructor- Health Science - North American College - Toronto, Canada

(2015-01 - 2016-12)

• Developed course curriculum and objectives for Applied Health Education. Taught Anatomy and Physiology, Systems Biology, Advanced Biochemistry and Molecular Biology courses.

Postdoctoral Fellow - Mount Sinai Hospital - Toronto, Canada

(2013-01 - 2015-12)

• Identified the exosomal miRNA biomarkers regulating inflammatory and angiogenic pathways.
• Developed physiologically relevant human cell-based models and functional assays to investigate angiogenesis and therapeutic responses. Cell-tracking analysis was performed using time-lapse microscopy.
• Investigated the therapeutic potential of modified heparins (LMWH) for the prevention of preeclampsia in clinical trial samples and matched tissues using RNA sequencing, IHC, IF, Flow, cell-based cytotoxicity, and Luminex assays. Protein-based functional assays were used to characterize placental-derived exosomes.
• Supervised graduate students and research associates; presented research at international conferences and won best presentation awards.

Postdoctoral Fellow - Princess Margaret Hospital - Toronto, Canada

(2011-01 - 2013-12)

• Investigated tumor-stroma interactions and cancer-associated fibroblast biology in NSCLC.
• Led functional genomics, identifying miRNA-mRNA networks and prognostic gene signatures.
• Applied functional genomics to analyze miRNA-mRNA interactions, validating 11 gene prognostic signatures in CAF-NF samples to guide therapeutic assessment.
• Developed a panel of RT-qPCR-sensitive assays to quantify mouse contamination in the primary cells from xenografts to achieve higher sequencing coverage and to improve downstream genetic analysis.
• Evaluated hormone-targeting therapies (estradiol, raloxifene, and fulvestrant) targeting ESR2 using shRNA lentiviral clones. Designed stimulation assays to identify CAF-specific signaling pathways in vitro.
• Designed and validated qPCR and sequencing-based assays for FFPE and xenograft samples.
• Supervised graduate students and research associates, presented research at international conferences.

Ph.D - Biochemistry - University of Mumbai (2003-01 - 2010-12)

M.Sc. - Medical Biochemistry - Manipal University (1996-01 - 1999-12)