● Leading the formulation, scale-up, and technology transfer for various Drug Product modalities, including LNPs, siRNA, and Biologics.● Developing novel formulations and processes for the delivery of innovative payloads in genetic medicine applications.● Managing technology transfer activities, overseeing the integration of proprietary technologies and fostering partnerships with external collaborators to adopt their processes and technologies within the organization.● Designing and executing scale-up studies to determine optimal operational parameters, assess the robustness of unit operations, and identify Critical Quality Attributes (CQAs) of Drug Product components using Design of Experiments (DoE) to set failure thresholds and control manufacturing processes.● Applying stringent quality analysis to Drug Product release specifications to resolve manufacturing deviations, and support the transfer of internal technologies to internal manufacturing and Contract Research Organizations (CROs).● Establishing and maintaining systems to ensure the timely execution and comprehensive documentation of studies, supporting Drug Product team milestones and justifying key strategic decisions.

● Subject Matter Expert (SME) and Lead for the scale-up and sterile production of LNP Drug Products dosed in non-human primate trials, achieving clinically relevant outcomes with a focus on meeting IND and DC requirements.● Oversaw Tech Transfer activities, including the implementation of proprietary technologies and management of relationships with external partners to integrate their technologies and processes within the organization.● Designed and conducted scale-up studies to establish operational parameters and evaluate the robustness of unit operations, defining Critical Quality Attributes (CQAs) of Drug Product components through Design of Experiments (DoE) to identify failure thresholds and control manufacturing processes.● Implemented rigorous quality analysis for Drug Product release specifications, managed the resolution of manufacturing deviations, and facilitated the transfer of internal technologies to external Contract Research Organizations (CROs) and clinical manufacturing partners.● Developed innovative formulations and processes for delivery of novel CRISPR-based mRNA and gRNA gene editing payloads, utilizing proprietary and commercial lipids (such as LP01, ALC-0315, CL1) for genetic medicine applications.● Led a team of two scientists while coordinating with cross-functional groups in a dynamic start-up environment, ensuring adherence to Quality by Design (QbD) principles and regulatory compliance.● Identified growth opportunities for team members, establishing actionable goals and timelines for their professional and scientific development, fostering an environment of constructive feedback and self-assessment.● Developed and implemented systems to ensure timely execution and thorough documentation of studies, supporting Drug Product team timelines and defending critical strategic decisions to senior leadership and across the company.

● Provided Late-Phase, Pre-Commercialization and Life-Cycle Management oversight and support for Small Molecule and Biologic matrixed product teams in global clinical and commercial GMP DS/DP/fill-finish manufacturing operations through understanding of process capability analysis, analytical commercial release parameters, troubleshooting, root cause analysis, and raw material product impact assessments.● Implemented knowledge of biologic and synthetic product structure-function relationships, quality, stability, impurities and analytical characterization to develop Monitoring Mater Plans, Commercial Release Specifications, and triage manufacturing deviations, non-conformance investigations and process challenges/improvements during development in Drug Product Technical Lead role.● Provided support for Subject Matter Expert rationale and data verification in Response to Questions (RTQs) from global Health Agencies (FDA, EMA, NMPA, PDMA, etc.).● Led coordination with and acted as single point of contact for external CROs and global cross-functional research teams to plan.● Led commercial Drug Product technology lab set-up at Amgen’s Massachusetts site to expand lab work capabilities and support Drug Product process development work for several commercial programs.● Responsible for planning, designing, executing, and documenting studies related to manufacturing processes for both Small Molecule and Biologic Drug Product design, formulation, and process development in support of commercialization and lifecycle management.● Designed, planned, and executed comprehensive studies assessing stability of Small Molecule and Biologic Drug Substance to support continuous process improvement effort at several clinical and commercial manufacturing sites.● Authored and reviewed guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developed responses to regulatory questions within validated quality systems.

● Leading role in matrix team supporting downstream Tech Transfer of Drug Product formulations to international GMP colleagues with successful implementation of all unit operations for Clinical Trial Phase I/II scale Engineering Runs and GMP facility productions, in line with Quality by Design principles.● Supporting RNA Lipid Nanoparticle Vaccine Phase III scale-up task force activities. This involves development of new processes, analytical characterization and introducing new technology to understand the feasibility of expanding formulation. These conclusions are communicated internally and externally to relevant stakeholders. ● Supporting development activities to execute Phase I/II testing of RNA Nanoemulsion Vaccine and RNA Lipid Nanoparticle Vaccine. These include formulation of development lots, supporting the complex in-use stability and withdrawal studies to assist dosage administration, as well as Technical Reports.● Supporting the formulation and process optimization of Biologic Peptide Antigen Vaccine for Phase III Clinical Trial Material; including antioxidant screening, lyophilization support, optimization, process compatibility, data analysis, technical documentation throughout, and presenting results within and outside of group. In addition, coordinated with several key stakeholders and team members. ● Leading characterization of Peptide antigen to support disease area task force activities, including protein unfolding with SPR and binding pathways for Peptide antigen and adjuvant with ELISA.● Development of Primary Packaging initiative for Drug Product final packaging material. This involves the feasibility of specific classes of vials, syringes etc., for use with our materials and their chemical compatibility and stability over time.● Awarded Global Patent Innovation Award for contributions to team developing improved microfluidic process essential for Lipid Nanoparticle Vaccine scale-up progression.

Screened pre-clinical discovery small molecule candidates to be used in radiolabelled diagnostic PET imaging of targets in neurodegenerative diseases, including Alzheimer's and Parkinson’s in a BSL2 LaboratoryDeveloped novel & streamlined existing medium/high throughput in-vitro screening assays via immunofluorescence on human brain tissueExecuted autoradiography experiments on human brain tissue slices with 18F labeled radioactive solutionsIntroduced historical archives for analytic validation of lead molecules to advance within the discovery pipelineDissected and sectioned frozen human brain tissue for use during in-vitro assays, and developed a tracking archive for allocation to weekly experimental planningAttended scientific conferences for international & regional audiences focusing on neuroscience research, and presented new research and technologies to increase productivity to upper management

Executed high-resolution medium/high throughput surface plasmon resonance (SPR) screening Affinity and kinetic data analysis for molecule identification and/or validation of ‘lead’ and ‘backup’ biologics molecules in the early discovery pipeline.Methods development and determination of affinities for mono-specific and multi-specific antibody candidates using recombinant or whole cell assays with ProteOn, Biacore and Biomek Automated WorkstationReported experimental methods and results in accordance with strict Discovery Data Integrity (DDI) guidelines.

Developed novel cleaning optimization test methods for manufacturing using Quartz Crystal MicrobalanceIntroduced methods that may lead to significant cost and time savings for the companyPresented work to senior leadership, including PSAA Vice President, and at Regional conferenceCommunicated experimental results clearly in Quarterly Reports, Work Instructions, and Lab Notebooks

Applied morphometric analysis to histopathologic Immunotoxicology / Experimental Pathology projectsConducted microscopy & morphometric components of Immunotoxicology / Immune Surveillance experimentsDeveloped global database solution for histopathology digital image analysis using Aperio systemsPresented results at team meetings and to leadership

Selected from competitive pool of applicants based on academic achievementResearched Fetal Lung Development as a Model for Human Lung Tissue EngineeringExecuted research tasks in tissue histology, including embedding, sectioning & staining tissues.Presented results of successful experiments via research poster at STAR Summer Showcase

Studied pediatric injury in partnership with Children's Hospital of Philadelphia & University of VirginiaCreated 3-D models of pediatric patients with Mimics softwareTransformed each rib's global data point to local coordinates using MATLAB