Kate Lee, Phd Email & Phone Number

San Francisco Bay Area

-Network New Technology Implementation Strategy Lead across 6 global mfg sites-Single Use Technology Assessment & Implentation-BPOG Extractables & Leachables Roche Representative [Peer-reviewed White Paper Publication: Lee, K. et al. (2020). Comprehensive Review of Biophorum Standardized Extractables Testing Data: A Deep Dive into Similarities, Differences, and Trends Across Extraction Solvents and Time Points. BioPhorum Operations Group.]-Phase 3 Clinical Campaign Cell Culture Lead-CMO Commercial Product Tech Transfer, Downstream Process MSAT Support

San Francisco Bay Area

(1) Materials of Construction (MOC) Technical Assessment for Bioprocessing-In compliance with regulatory requirements for product quality impact and patient safety, provide technical support (general extractables and leachables testing, chemical compatibility, and toxicological assessments for stainless steel, ceramics, plastics, and elastomers used in bioprocessing equipment) and streamline business processes as a subject matter expert in MOC for clinical and commercial operations-Publication: Magarian, N. et al. (2016). Clearance of Extractables and Leachables from Single-Use Technologies via Ultrafiltration/Diafiltration Operations. Biotechnology Progress, 32(3), Vol 32, 537-817.(2) New Technology Support: Single-Use Technology (Disposables) in Bioprocessing-Provide novel and innovative single-use technologies for clinical and commercial operations by leading, designing, testing, and providing data package(3) Phase II, Ocular Drug Clinical Study, Formulation Stability Study-Support Phase II clinical trial of ocular drug by (a) designing formulation stability experiments, (b) executing experiments (characterization of protein and excipient stability at multiple time points via various analytical tools), and (c) performing data analysis to support ongoing toxicology study and formulation knowledge development for Phase II clinical trial

Atlanta, Ga

Designed and characterized a novel gold nanoparticle-based, multifunctional drug delivery agent via bioconjugation of doxorubicin (a dual function of chemotherapeutic agent and SERS spectroscopy reporter) for simultaneous cancer therapy and detection. Engineered a pH-sensitive, small-sized gold nanoparticle drug delivery system for solid tumor treatment. Conducted in vitro and in vivo studies for therapeutic efficacy of a gold nanoparticle drug delivery system. Examined and compared the pharmacokinetics of small and large gold nanoparticle systems in a mouse model.

Atlanta, Ga

Rotation I Advisor: Dr. Julia BabenseePrepared polymeric biomaterial scaffolds (PLGA & PDMS). Evaluated the mechanism of immune responses (protein assays, SDS-PAGE, immunoblot analysis) triggered by implantation of biomaterial in a mouse model. Developed a Western blot protocol, specifically tailored to the analysis of retrieved exudates from in vivo study.Rotation II Advisor: Dr. Robert TaylorExplored the role of renin receptors in angiotensin II production. Prepared cryosections of blood vessels and heart for immunohistochemical analysis. Performed mouse surgery to induce hind limb ischemic injury.

Austin, Tx

Accenture eDemocracy Services, Election Management Software (EMS) Product for Colorado, Wyoming, and Wisconsin: Performed product testing in functional areas of software. Documented and resolved issues with the programming script. Prepared test scripts for further analysis. Security and Network Protection Software Product for Oregon State:Conducted product testing for validation of encrypted security network software. Administered employee training to a class of 30 state workers on software usage.

Austin, Texas

Advisor: Dr. Nicholas PeppasPerformed a study on oral drug delivery for chemotherapy. Fabricated microparticles under inert conditions for bleomycin delivery. Analyzed the effectiveness of bleomycin-loaded microparticles with animal cells, using TUNEL assay.

Atlanta, Ga

Advisors: Drs. Peter Ludovice & Mark PrausnitzFocused on a transdermal drug delivery study using electroporation and Magainin peptide. Analyzed the flux through hairless rat skin using fluorescently-tagged molecules and spectrofluorimeter. Modeled peptide using CERIUS2 and HyperChem software. Provided a written report and oral presentation to faculty members from the Schools of Chemical and Biomedical Engineering.

Austin, Tx

Advisor: Dr. Christine SchmidtInvestigated the regeneration of nerves and blood vessels using acellular nerve graft and biomaterial (hyaluronic acid hydrogel). Prepared and analyzed rat sciatic nerve sections using various immunohistochemistry-staining methods.

Doctor Of Philosophy, Biomedical Engineering

Activities and Societies: Bioengineering and Biosciences Unified Graduate Students (BBUGS), Biomedical Engineering Society (BMES).

Bachelor Of Science With Honors, Chemical Engineering

Activities and Societies: Secretary & Treasurer for Omega Chi Epsilon Chemical Engineering Honor Society, Student Engineering Council.