Alessio Buscaglia

Analytical Validation & Services Senior Coordinator presso Cerbios-Pharma SA

Lugano, Ticino, Switzerland

About

Analytical scientist with about 10 years of experience in R&D and GMP analytics, specialized in Antibody Drug Conjugates (ADCs), Antibody Proteases Inhibitors Conjugates (APICs), Nanobodies and all kind of Conjugates. Proven expertise in analytical method development, validation, in-process controls, GMP release and stability testing. Skilled in HPLC (SEC, HIC, RP), CE-SDS, cIEF, ELISA, SoloVPE, Western blot, enzyme and endotoxin assays, characterization of mAbs and ADCs by LC-MS. Strong background in DoE-based method development, CMC support, analytical dossiers and stability protocols. Currently leading a team of 9 scientists at Cerbios-Pharma SA, coordinating complex analytical packages for biopharmaceuticals. Recognized for bridging scientific innovation with regulatory-compliant solutions and for delivering value to clients.

Experience

  • Cerbios-Pharma SA (Full-time · 5 yrs 5 mos)
    • Analytical Validation & Services Senior Coordinator
      May 2026 - Present · 3 mos

      I lead and coordinate a team of 9 scientists working on ADC (Antibody Drug Conjugates), APIC (Antibody Proteases Inhibitors Conjugates), nanobodies and all kind of conjugates analytics. Our activities cover analytical method development and qualification/validation, in-process controls, as well as GMP release and stability testing. I regularly interact with customers to present data and to prepare budget offers for analytical work packages

    • Analytical Validation & Services Coordinator
      May 2025 - May 2026 · 1 yr 1 mo

      I lead and coordinate a team of 9 scientists working on HPAPI (drug-linker) and ADC analytics. Our activities cover analytical method development and qualification/validation, in-process controls, as well as GMP release and stability testing. I regularly interact with customers to present data and to prepare budget offers for analytical work packages

    • R&D/GMP BioAnalytical Specialist
      Oct 2023 - May 2025 · 1 yr 8 mos

      Supervisor role in CDMO R&D/GMP analytical department mainly focused on Antibody Drug Conjugates (ADCs).

  • R&D Scientist at Lonza
    Nov 2019 - Mar 2021 · 1 yr 5 mos

    R&D Scientist mainly focused on process and analytical methods development using a Quality by Design approach through the Design of Experiment.

  • QC Analyst Team Leader at Balchem Corporation
    Apr 2012 - Sep 2015 · 3 yrs 6 mos

    QC Analyst in the field of methylamines and methylamine-derived products (choline). Activities: analytical method development and troubleshooting, periodical check of the instruments as required by GLP, management of sample for external analyses. Analytical instruments: HPLC, ionic chromatography, gas chromatography (also with Headspace configuration), Karl-Fischer, NIR, titrators.

  • QC Analyst at ACQUA NOVARA.VCO S.P.A.
    Jun 2010 - Jul 2010 · 2 mos

    Extracurricular internship. Analytical instruments and analyses: ICP, ionic chromatography, microbiological analyses, titrations