• Design, Develop and drive pre-clinical and clinical assays in regulated environment (GLP, GCLP, CLIA) and biomarkers strategies across functional therapeutic areas with emphasis in CRISPR/Cas9 edited stem cells based autologous hematology and allogeneic CAR-T cell based immuno-oncology programs. • Identify appropriate CRO to conduct in-vitro and in-vivo pharmacology studies and work closely with QA to conduct on-site technical audits to evaluate their scientific capabilities as well as compliance to CLIA/ISO/GLP/GCLP guidelines.• Lead internal teams and external partners/CROs through the development, qualification and validation of critical assays for clinical evaluation of novel cells-based therapeutics under tight timelines.• Interact with KOLs and external collaborators.• Support advancement of drug candidates from discovery to clinical trial execution by collaborating with the discovery and development functions to provide strategic biological, biomarker and clinical guidance.• Contribute to authorship of non-clinical IND enabling safety study reports, invention disclosures, IND applications, and other regulatory documents.• Design, manage, analyze, and report studies aimed at informing pharmacodynamic biomarkers, predictive biomarkers, and mechanisms of action for drugs in various phases of development.

• Responsible for the coordination and oversight of genetically engineered murine model identification(genotyping)/creation, genetic monitoring of mouse and rat models, gene expression and PCR/qPCR based assay development activities for CRL and external clients. • Led internal R&D activities. Designed and validated qPCR based non-human primate (NHP) blood group typing assays which have been a source of steady revenue for the company. Designed and validated DNA isolation method from single blastocyst for the downstream monitoring of the gene editing events. Designed and validated rat MAX-BAX SNPs testing panel.• Managed project logistics with internal scientific staff and external contract research/resource organizations (CROs) to ensure adherence to study time lines and protocols. • Led troubleshooting efforts for issue resolution. • Participated in strategic business planning. • Evaluated, recommended, and implemented latest technologies to improve productivity, increase efficiencies, and reduce costs. Qiacube HT for mid- to high throughput gDNA and RNA isolation. MALDI-TOF based MassARRAY® System for high throughput SNP testing for mouse and rat genetic monitoring.

Served as an independent scientific and technical consultant to Biotech/Biopharmaceutical companies for development of cell based bioassays and in-vitro diagnostics (IVDs).

My research at the Boston Children’s Hospital was focused on studying molecular and genetic mechanisms governing hematopoiesis. I studied role of several genes in hematopoiesis and related immune disease by generating and characterizing a series of preclinical proof-of concept and mechanism-of-action in vivo animal models of human inflammatory, autoimmune and primary immunodeficiency diseases. I also extended these studies to in vitro (primary cells and cell lines of murine and human origin) models. In addition, I:• Led research activities to achieve program and project-level goals.• Planned and effectively communicated research goals and objective to junior scientific staff for the timely completion of research projects. • Presented data in-house and at various national and international scientific meetings in a variety of formats (oral, poster and panel discussion). • Assisted in writing and reviewing of SOPs, manuscripts and research grant proposals. • Trained, supervised and mentored junior associates (research assistants, post-doctoral and clinical research fellows). • Introduced latest concepts/technologies such as PLA (Proximity Ligation Assay) and CRISPR-Cas9 to research programs to achieve research goals and objectives more efficiently.• Managed interactions with internal and external scientific collaborators in academia, industry and CROs. The above work led to 3 successful research grants from NIH and a private organization, the publication of 17 manuscripts in high impact journals, and training of several post-doctoral and junior technical staff.

Led research projects aimed at the investigation of structure-function relationship of different signaling domains of adaptor proteins SLP-76 in the development and function of T cells and bone marrow derived mast cells (BMMCs). Successfully achieved objectives of these projects by: • Designing and generating several different SLP-76 DNA expression constructs for the retroviral reconstitution of SLP-76 deficient BMMCs (derived from SLP-76 knockout mice). • Designing and generating a series of tissue specific wild type and different mutant SLP-76 transgenic mouse models and breeding them in to the SLP-76 knockout background. • In-depth phenotypic characterization of the reconstituted BMMCs and transgenic mouse models.The data generated in these studies resulted in one successful R01 grant from NIAID, NIH and publication of several manuscripts in high impact journals.