"My passion is to accelerate the development of novel therapeutics to improve patients’ lives and have an impact on unmet medical needs."
I’ve worked in pharmaceutical industry for 15+ years at both small and large organizations. Early in my career, I supported early stage development of API and Drug products. Attracted by Genentech’s focus on science and innovation, I joined the Small Molecule Analytical Chemistry department at Genentech in 2009 and continued leading the analytical chemistry efforts for pre-clinical and early clinical product development. As an analytical project lead, I had the privilege of developing the analytical strategy for several key programs and working with talented colleagues on cross-disciplinary teams.
Since 2014, I have been leading the Process Analytical Group where I am directing analytical chemistry efforts to guide the process chemistry synthetic route development from early stage (pre-clinical) to commercial phase. My team also provides analytical support for the synthetic scale-up activities of API, including in-process control strategy for dose range finding, GLP-tox and clinical campaigns. In this role, my group contributes to nearly every one of our small molecule GDC programs. I enjoy the diversity of science conducted at Genentech as it challenges us and encourages for deeper understanding. I have lead the implementation of Process Analytical Technology (PAT) to enhance process understanding during early development. In addition to PAT, my research interests include trace level genotoxic impurity analysis, rapid elemental analysis and faster separations. I also represent Genentech/Roche on the board of Enabling Technologies Consortium (ETC).
The primary focus of my group is to identify, develop and use state-of-art analytical techniques to help chemists build process knowledge and understand reaction mechanisms and kinetics. Using traditional and advanced analytical technologies, we also develop methods to efficiently guide process chemistry synthetic route development and characterization of new drug therapies, ensuring the control strategy is built-in and the final API will meet the target specifications at the time of release.
My research interests include PAT which enables real time analysis for batch and flow processes, trace level genotoxic impurity analysis, X-ray fluorescence (XRF) for quick elemental analysis and Super Critical Fluid Chromatography (SFC) for faster separations. The ability to measure reactions and crystallizations in-situ enables deep process understanding and reduces exposure risks. Under my leadership, the PAT team has implemented numerous different technologies including ReactIR, Particle View Microscopy, Focused Beam Reflective Measurement, Raman, and probes for oxygen/pH/conductivity. I am a strong advocate for new technologies and am currently in the process of developing new technologies through an ETC in collaboration with other pharmaceutical companies, technology vendors and academia.