Project Manager supporting the transfer, qualification, and validation of GMP Potency assays for the characterization and release of Cell and Gene Therapies.

-Specializing in In Vitro, Ev Vivo, and In Vivo ADMET assays for screening and regulatory submission-Proposes and Develops new assays and scopes of work based on emerging research and market demand-Workes closely with the Territory Sales Manager and Support Services (Business Development, Upper Management, Scientific Managers, Technical Operations, and Marketing) to win new business and increase sales to existing customers as well as coordination and communication between functions.-Routinely Assists In Vivo Lab with routine dosing and sampling procedures

-Served as single point of contact for West Coast clients as sales and scientific liaison -Maintained and Diversified existing client relations while Expanding client base-Lead client engagement with prompt and accurate communications-Followed internal processes for accurate record keeping of study designs, proposals, pricing logic in CRM and internal document management system-Worked with Marketing Lead to develop and implement new scientific collateral, marketing campaigns, and new online store offerings

-Served as a DMPK Technical Resource for the Global Sales Team -Designed studies and screening study programs that meet sponsors’ needs in a scientifically sound and operationally effective manner-Designed definitive Transporter and Metabolism studies to satisfy requirements of Global Regulatory agencies (i.e. FDA, EMA, PMDA) for NDA Submission -Continuously evaluated and applied new scientific methodology in order to maintain scientific or technical excellence, to increase productivity, to meet research and drug registration needs

-Performed routine animal handling and test article administration (po, sc, ip, iv) in mice and rats, monitor animal health, collect blood samples, measure tumors, perform necropsies and collect and record data.-Coordinated and communicated with sponsors and scientists to draft, finalize and execute study protocols-Assisted with the development of new animal models, including pilot studies and troubleshootingPerformed surgeries under clean conditions including implantation of cannula for sampling (JVC) -Ensured nonclinical studies are conducted in compliance with approved study protocols, Standard Operating Procedures (SOPs), and, as applicable, IACUC and AAALAC guidelines