• Efficient People’s manager along with scientific and management leader of multiple cross-functional projects in Drug Discovery and Pre-clinical/Clinical Development of infectious diseases.• Developing large molecule complex biological drugs (genetically modified virus) as NME (New Molecular Entity), by preclinical experimentation, in-vitro assay development with or without SoC (Standard of Care) antibiotics (Small molecule), successfully accomplished NME declaration as a cross-functional Project Management Leader for a complex biological drug via Intravenous (IV) for Cystic Fibrosis and Non-Cystic Fibrosis patients with a range of key stakeholders to prepare NME documentation along with clear data-driven innovative and efficient clinical development plans. Provided guidance to the stakeholders for Global regulatory and quality guidelines. • Strongly and actively supporting post-NME activities including FDA (Briefing Book, IND, NDA) and EMA regulatory submission, CMC process development and quality operations, pre-clinical safety (toxicology – FDA, ICH), checkerboard assay and pharmacokinetic/pharmacodynamic (PK/PD) with SoC antibiotic, biomarker, immunogenicity assay like anti-drug antibody (ADA), neutralizing antibody (NAb) assays, analytical (ICH Q2R2) and bioanalytical (ICH M10) assay (QPCR, ELISA, Immunoassay, NGS) development and validation using laboratory automation (Biomek, Hamilton), SOP writing to compliant with drug development and manufacturing (GMP) required for regulatory communications along with business operation including strategic planning, relevant marketing and sales.• Efficiently optimized and validated microbiology test methods based on global regulatory standards (CLIA, FDA), transferred to CRO and ensured clinical practice guidelines (CLSI, EUCAST) to support GxP compliant clinical trial (Phase 0, Phase 1b/2a) activities like designing clinical samples handling, processing and evaluating for drug products (DP) and drug substances (DS).

• Involved to develop rapid in vitro clinical diagnosis (IVD) of bacterial ID and antibiotic (Small molecule) susceptibilities for clinical respiratory pathogens using single-cell digital culture technology to fight against drug resistance presents one of the greatest public health challenges and received FDA “Breakthrough Device” designation.• Successfully developed and optimized Resorufin-based electrochemiluminescence (ECL) signal detection multiplex assay in MesoScale Discovery (MSD) platform to analyze a range of small molecules as substrates for bacterial metabolism and transferred the assay in automated single-cell platform. • Generated the development plan including manufacturing based on FDA regulatory guidelines.

• Conducted cell and gene therapy clinical research. Successfully developed new stable recombinant human cell lines using lentiviral vector gene editing system (viral vector engineering) through extensive hands-on work with human cell (suspension and adherent like T lymphocytes, leukemia monocytic, embryonic kidney cells) culture. Developed high throughput multiplex immune response assays using fluorescence signals, RNAseq assay and NGS.• Small scale production of recombinant lentivirus, quantification of viral vector.• Excellent leadership, management and high-level strategic planning to drive cross-functional teams and leading by influence to develop and ensure successful execution demonstrated for team working in DARPA funded project with Artificial Intelligence/Machine Learning Algorithm, microfluidics and clinical microbiology exploring single-cell analysis for rapid and high throughput detection of pathogenic bacteria to develop an integrated technology platform (iSENTRY) that performs to reduce threats to warfighters and civilians. • The approach successfully established a phenotype-based (virulence, toxicity, innate immune response) ML pipeline for potential pathogenic threat assessment with previously machine-observed and unobserved bacteria with 99% and 85% accuracy, respectively and yielded a joint first author PNAS publication.

• Excellent teamwork, strong leadership and decision-making skills demonstrated to design (statistically validated), set up, conduct, recruitment activities, closeout, and reporting results with statistical validation of therapeutic field trials for six years in multiple locations in US, resulting in regulatory approval from USEPA & CDPR.

• Strong communication and management skills demonstrated by successful completion of multi-site field trials, statistical analysis using R software. Efficiently led Process Development (upstream and downstream bioprocessing, scale-up from 1L to 30L bioreactors) of bacterial fermentation for DP/DS production in Good Laboratory Practice (GLP) manufacturing facility and quality control assays. • Evaluated new bacteriology targets, therapeutic concepts, and therapeutic agents (Peptides/Proteins). Managed a team of high-performance scientists. Supported the evaluation of external licensing opportunities. Independently outsourced and managed product development to contractors and solution suppliers in the global marketplace. Designed and guided the execution of decisional experiments and in-vitro model development. Creation, approval, and execution of integrated project plans by integrating strategic and tactical input from diverse disciplines (e.g., clinical, regulatory, market access, manufacturing, CMC, commercial, and other areas) as applicable to the project.

• Outstanding project leader who facilitated the completion of multi-institutional collaborative Otsuka Pharmaceutical funded R&D project to develop biological to control Pierce's Disease by leading a team of researchers, resulting in award-winning patents and a press release recognized and cited by 40 different news media in USA and Europe.• Analyzed and interpreted complex data sets, interconnecting results from molecular and microbiology assays, resulting in significant findings on discovery of first virulent Xylella phages, genomic sequencing using NGS, develop diagnostic qRT-PCR, ELISA and phage therapeutic efficacy, as evidenced by 3 publications, 8 conference proceedings and a book chapter.• Demonstrated ability to function in an interdisciplinary team setting, having worked closely with 5+ cross-functional experts and successfully trained personnel during the tech transfer of assays from R&D to GMP scale-up to CDMO, QC and non-clinical safety (toxicology) under GLP. Effectively trained less experienced personnel, acting as a resource for providing scientific expertise along with business operation including strategic planning, relevant marketing and sales. Actively involved in eIND filling, preparation of documents, develop immunogenicity assay.

■ Involved on development of stable and cost-effective DNA vaccines for silencing genes of White Spot Syndrome Virus in Penaeus monodon through RNA interference (RNAi).

• Efficiently worked as team member in WHO recognized Collaborative Center for Research and Training on Diarrhoeal Diseases to routinely evaluate (IVD) clinical samples and prepared reports.• Successfully managed five multi-faceted projects simultaneously by strong problem solving and analytical skills as evidenced by nine publications and five conference proceedings.• Independently developed a protocol for whole genome sequencing of first typing vibriophage and phenotypic and molecular profiling of clinical Vibrio cholerae isolates, surveillance using Multiplex-PCR, demonstrated current trends of phage typing schemes.• Demonstrated strong scientific and creative knowledge by designing and accomplishing experiments resulted remarkable in vivo therapeutic efficacy of vibriophages against experimental cholera.• Actively involved in cholera vaccine trial program and multiple outbreak investigation conducted by NICED in India by handling and evaluating clinical samples.