Kevin Blanco Valle

Bioanalytical method development for protein therapeutics: ELISA, multiplexed detection platforms, SOPs, validation protocols and regulatory compliance documentation (GxP).
Cross-functional collaboration with QA, regulatory affairs, and CRO partners across the drug development pipeline.

Developed analytical methods for protein therapeutics: stability, polyreactivity, solubility and developability assays (SEC-MALS, HIC, DSF, WB). Assumed sole ownership of HPLC/MALS systems — laboratory reference for instrument qualification and troubleshooting.
Contributed to internal analytical frameworks, SOP authoring, and CRO relationship management in a fast-paced biotech environment.

Developed and validated multiplex LC-MS/MS proteomic methods for staphylococcal enterotoxin detection at the EU Reference Laboratory — novel methodology co-published in 3 peer-reviewed journals (Toxins 2022; J. Proteome Research 2022; J. Agricultural & Food Chemistry 2021) and presented at 2 IAFP international symposia.
Contributed to the creation of ISO working group ISO/TC34/SC9/WG30, representing the EURL-CPS in international standardisation. Characterised European foodborne outbreaks using ELISA and LC-MS/MS.

Supported postdoctoral researchers in development and optimisation of LC-MS/MS methods for small molecules and proteins.

Founded and operated a product startup: P&L ownership, sourcing, production supervision, and team management — foundation of cross-functional business leadership competencies.