Lead preclinical to clinical development effort on a Phase 1 Influenza vaccine product- Managed project scheduling and resourcing to meet aggressive timelines- Planned and coordinated immunological and toxicological studies with multiple CRO’s- Developed scalable purification, sterilization, and finish process for a parenteral nanoparticle product: tangential flow filtration, sterile filtration, container/closure selection, and lyophilization - Involved in both informal and formal stability assessment of product. Coordinated product shipment, storage, and preparation for subject administration at CRO. - Heavily involved in the planning, method transfer, and execution of clinical trial material batch production at a CMO- Assisted in the writing, editing, and submission of INDInitiated proof of concept studies using PRINT® nanoparticles as next generation conjugate vaccines- Designed and fabricated particle compositions containing biological material - Developed assays to detect biological cargo and/or in vitro efficacy- Developed purification/processing procedures- Planned and coordinated immunological studies for lead candidates- Initiated informal stability studies early in program- Characterization of product using dynamic light scattering, zeta potential, optical microscopy, SDS-PAGE, plate based UV/Vis and fluorescence assays.- Involved in grant and proposal writing

Initiated proof of concept studies using PRINT® nanoparticles as next generation nucleic acid vaccines and for siRNA delivery - Designed and fabricated particle compositions containing biological material - Developed assays to detect biological cargo and/or in vitro efficacy- Planned and coordinated immunological studies for lead candidates- Characterization of product using dynamic light scattering, zeta potential, SEM, optical microscopy, fluorescence microscopy, western blot, SDS-PAGE, gel electrophoresis, plate based UV/Vis and fluorescence assays, cell-based assays, infrared spectroscopy- Involved in grant and proposal writing

- Collaborated with a multidisciplinary team of researchers to utilize the PRINT technology in the life sciences in the laboratory of Professor Joseph M. DeSimone. Explored applications in both nucleic acid delivery and in vaccines.- Developed methods to fabricate PRINT® nanoparticles containing nucleic acids- Manufactured particles for in vitro and in vivo analysis- Analyzed particles for particle integrity, particle size, and biomolecule loading - Additional responsibilities included the mentoring of students and contributions to grants and proposals