"Genentech is such an amazing and rewarding place to work because of its purpose to help patients by driving cutting-edge science. It’s also fun to interact with many incredibly talented and dedicated people and immerse yourself in its challenging yet nurturing culture. I’ve learned so much about how to translate science into medicines and I am still on the learning curve. Genentech also provides opportunities to me and helps me growing into a leader. With all that, I am inspired and excited to come to work every day!"
I joined Genentech in 2002 as a Scientist contributing to the development of bioassays/potency assays for development molecules. Soon my responsibilities expanded to all bioanalytical strategies and methods for the evaluation of pharmacokinetics (PK), anti-therapeutic antibodies (ATAs) as well as biomarkers to support biotherapeutic development, regulatory filing and approval. In 2006 I was promoted to Senior Scientist and started to lead a group of 10 people. I was appointed to Associate Director in 2008 and started to lead the department of Assay Development & Technology (ADT) (formerly BioAnalytical Research & Development [BARD]) in 2009. I am currently the Director of ADT overseeing ~60 employees and accountable for bioanalytical assay development, validation, outsourcing, and performance for Genentech Research & Early Development (gRED) biotherapeutic pipeline from ED (including selected LSR projects) to post-marketing.
During my time at Genentech, I also contributed to drug development and approval by leading cross-functional teams as Pharmacology Subteam Leader (PSTL) and Biomarker Subteam Leader (BMSTL). I personally contributed to 10+ IND, BLA and global regulatory filings and participated in global health authority interactions. I am a reviewer of Development Review Committee (DRC), Diagnostic Review Forum (DxRF), Development Sciences Review Group (DSRG), and BAS Review Group (BASRG). I also served as a member of the Development Sciences Promotion and Appointment Committee (DSPAC).
Bioanalysis. 2015 Dec;7(24):3107-24.
I am currently leading the ADT department responsible for developing state-of-the-art methods for the assessment of pharmacokinetics, pharmacodynamics, immunogenicity, diagnostic biomarkers, and in vitro pharmacology activity of Genentech pipeline biotherapeutics from Early Development (ED) to post-marketing. The department utilizes multiple immunoassay technologies (ELISA, ECLA, Luminex, IMPACT, Gyros, Singulex, Quanterix, SimplePlex, etc), mass spectrometry, SPR, and cell-based assays, and continues to drive novel bioanalytical strategies and technology innovation. My main focus is to set scientific and strategic directions for ADT, to manage organizational goals, and to develop people and teams.
Outside of my own function, I am the Pharmacology Subteam Leader (PSTL) and core member of the Global Development Team (GDT) and Life Cycle Team (LCT) of a late-stage molecule and contribute to its development and life cycle strategies.
Outside of Genentech, I am an executive member of the Biotechnology Section of the American Association of Pharmaceutical Scientists (AAPS) and will assume the chairmanship for the Therapeutic Product Immunogenicity Focus Group (TPIFG) in 2017-18 (currently Chair-elect). I am also on the US Pharmacopeia Convention “Immunogenicity Testing Expert Panel”.