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.