🔹 Experienced analytical scientist with a focus on developing cell based and molecular assays for multiple C> products as well as establishing quality criteria by defining CQAs, designing system suitability criteria and generating reference standards and stability testing guidance. 🔹 Worked on developing cutting edge and novel assays utilizing immune assay techniques like multi-color flow cytometry, MSD, cell-based assays, etc. to understand the functionality of T cell-based drug products used in treating rare and deadly forms of cancer. 🔹 Worked cross functionally in a matrixed environment while serving as a subject matter expert (SME) in establishing novel analytical methods, solve technical challenges and support various departments within and outside CMC while ensuring compliance with regulatory standards.🔹 Part of the CMC Strategy team working with Quality and Regulatory to develop filing strategies, formalizing drug candidate criteria selection, evaluation of contract organizations and managing external relations with multiple collaborators. 🔹 Managed 3-4 direct reports and leading a small team of researchers while collaborating within the department and outside to innovate and advance the analytical process.

🔹 Provided guidance, direction, training and leadership to the cell based and potency assay team by serving as the team lead within the Analytical Development group.🔹 Monitored qualitative and quantitative achievement of the team while managing a direct report and provided support to the functional manager/director of the Analytical Development group by maintaining an effective communication channel within the group.

🔹 Highly motivated and driven analytical development scientist with experience in leading the development and technology transfer of time sensitive release assays and authoring and reviewing technical documents for method establishment, assay development, assay qualification and validation. 🔹 Introduced and developed novel assays including single cell VCN determination of drug product, T cell differentiation to establish potency and functionality of gene therapy product and iPSC cell line engineering using CRISPR/Cas9 to establish disease model.🔹 Authored SOPs and study protocols, lead assay development and trained QC personnel thus supporting process qualification and validation runs.🔹 Lead technology transfer of multiple critical assays from academic institutions by successfully completing comparative study protocols as well as played an instrumental role in transferring qualified assays to CDMO for clinical monitoring.🔹 Extensively collaborated with Process Development, Quality and Manufacturing teams in validating manufacturing processes and preparing regulatory documents for IND applications.

🔹 Directed time-sensitive projects in pre-clinical testing of 3 novel inhibitors and drug combinations for treating myelofibrosis resulted in an R21 grant funding of more than $400,000, resulting in two publications (1, 2) and a clinical trial currently in Phase 2.🔹 Evaluated publicly available clinical data and RNA-sequencing data from patient samples to identify novel biomarkers to design an innovative strategy for pattern recognition to examine the validity of these biomarkers in the relevant signaling pathways.🔹 Isolated and processed CD34+ cell sub-populations from patient PBMNCs and bone marrow, performed target identification using ELISA, immunohistochemistry, and RNA-sequencing, followed by kinase inhibitor treatment and analysis using functional assays and molecular biology techniques like qRT PCR and western blot.🔹 Expert in a wide array of cell and molecular biology techniques like transfection, viral transduction using lentivirus and retrovirus, molecular cloning, CRISPR/Cas9-based gene knockout, etc., used inunderstanding the role of key tumor suppressors and oncogenes in cell lines and primary cells of hematopoietic oncology.

🔹 Strategic thinker and efficient learner who devised an innovative and multifaceted thesis project in epigenetic regulations of myeloid malignancies resulting in 1 second author publication and 1 manuscript in preparation and significant contribution to multiple grant funding in excess of $200,000 per year for multiple years🔹 Gained insight into the role of DNA methylation modifiers in myeloid malignancies in an in vivo leukemic mouse model using bone marrow transplantation model and flow cytometry-based approaches to study hematopoietic stem cells🔹 Establishment and optimization of novel epigenetic methodologies including ChIP and RNA-IP and genome editing techniques like CRISPR/Cas9 resulting in 2 new projects and incorporation of these techniques into 3 existing projects🔹 Gained proficiency in oral communication by delivering engaging seminars and poster presentations at 5+ conferences, as well as in scientific writing achieved by preparing manuscripts, reviewing protocols and writing and editing grant proposals🔹 Proficient team player with a penchant for collaborative research as demonstrated by multiple collaborative projects both internal and external🔹 Successful mentoring of 4 graduate students, multiple rotation students and clinical volunteers on specific techniques and actively participated in lab management including ordering, inventory management, equipment maintenance, demo setup and communication with vendors

🔹 Efficiently mentored high school and freshman year college students from USA in Mathematics, Chemistry and Biology, using voice call and/or blackboard mediated interface. 🔹 Provided consultation and conducted demos and free sessions for parents as a part of the pre-sign-up trial.

🔹 Gained experience in sperm preparation and quality assessment techniques, sperm and ovum cryopreservation techniques as well as routine ELISA techniques for detection of hormones in pregnant women.