Rafael Sande

Background

About Rafael Sande

As a CMC Analytics Leader with 13+ years of experience, I help pharma and biotech organizations bring breakthrough biologics and novel therapies from pre-clinical to market. My career has been dedicated to building advanced analytical strategies that not only solve complex technical challenges but also accelerate development timelines, mitigate risks and ensure regulatory success. I’ve guided analytical CMC programs across the full drug development life cycle—from pre-clinical through commercial—delivering analytical solutions that support innovation while safeguarding product quality and compliance. What drives me is a clear mission: enabling the delivery of life-changing therapies to patients who need them most. I thrive at the intersection of science and leadership, helping organizations translate complex analytics into meaningful outcomes for both business and patients. Core Expertise • CMC analytics for Biologics & Cell-/Gene Therapy products (pre-clinical → commercial) • Structural & functional protein characterization: PTMs and impurities, glycosylation, higher-order structures, aggregates, fragments • Advanced mass spectrometry applications: LC-MS/MS for protein CQAs, N-/O-glycosylation, PTMs, Disulfides, Free Thiols • Multi-attribute methods under GMP • Potency & impurity assays, absolute quantification in complex matrices • Epitope mapping, comparability studies & protein interaction analysis (HDX-MS, Native Protein MS) • MALDI-MS, RNA/DNA analytics, AAV & LNP characterization What I bring: Deep technical expertise in CMC analytics & regulatory expectations Proven success advancing biologics and gene therapies to clinical & commercial milestones A collaborative, solution-oriented approach to complex analytical challenges Always open to connecting with professionals in biologics, cell/gene therapy, novel therapies and CMC analytics in general to exchange insights, explore partnerships, or discuss innovation in the field.