Lan
Executive Director @Aurion Biotech
Signup · Get unlimited contacts
WORK HISTORY
Executive Director @Aurion Biotech
Manage functional verticals including External Manufacturing, Manufacturing Validations, and MSAT. Maturing org through late stage and licensure.
EDUCATION
The Johns Hopkins University
BS, Biomedical Engineering
The Johns Hopkins University
MSE, Mechanical Engineering
UC Berkeley extension
Certificate in Leadership and Management
SKILLS
ABOUT LAN
Scientist, Engineer, and People Leader | Cell Therapy & Biologics | MS & T | Formulation/Process DevelopmentWith 15+ years of experience in MS & T and formulation/process development, I am a technical professional specializing in the manufacture of cell therapies and biologics, including bispecifics, mAbs, and ADCs. Currently, I serve as an individual contributor, matrixed team lead for a commercial cell therapy product, overseeing production, delivery, LCM changes, improvements, and supply expansion.The promise of autologous cell therapy and its one-lot-per-patient scale-out model captivate me, emphasizing the significance of CMC (Chemistry, Manufacturing, and Controls). Throughout my career, I have acquired extensive knowledge in cell therapy manufacturing processes, successfully led tech transfers to CMOs, and managed teams for cell therapy introduction in clinics and commercial markets (US/EU/JP). This includes tactical execution, validation strategies for PPQ, root cause analyses, and overseeing teams of up to 13 FTE.With a robust track record in regulatory affairs, I have authored CMC sections for IND/CTA submissions, covering facilities, molecule characterization, stability, drug delivery, and control systems in biologics. I have navigated Health Authority meetings and adeptly responded to information requests / regulatory queries from FDA/PMDA/EMA for submissions in Cell Therapy.Previously at Genentech, I found fulfillment in providing medicines for unmet medical needs. After a two-year sabbatical exploring the world, I re-entered the biotech workforce in Seattle\'s vibrant community. In my prior role at a start-up, I embraced versatility, leading Formulation/Downstream Processing (UFDF) development, managing RFQs for CMOs, reviewing batch records and deviations, and spearheading tech transfers. I devised an innovative logistics strategy for DS/DP transportation and successfully influenced its implementation.Fuelled by a passion for continuous learning, product improvements, and deep technical understanding, I have authored manuscripts, delivered presentations, and secured patents. My experience includes development studies using DOE, long-term GMP stability support, TT to CMOs, and alignment facilitation across management and cross-functional teams.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.