Gwenaël NYS
Liège
Summary
Strategic CMC and Analytical Sciences leader with 10+ years specializing in quality control and characterization of monoclonal antibodies and recombinant proteins. Proven expertise in analytical lifecycle management, CMC strategy and regulatory dossier authoring. Active laboratory involvement in developing and implementing innovative solutions with direct access to state-of-the-art analytical facilities.
Drives scientific excellence through collaborative leadership, transforming analytical challenges into efficient, regulatory-compliant solutions.
Overview
11
11
years of professional experience
Work History
Chromatography and Mass Spectrometry Team Lead
Sanofi
06.2021 - Current
Quality Control & Characterization
- Led QC strategy for monoclonal antibodies and recombinant proteins
- Supervised method transfers and validation across global sites
- Resolved complex quality issues through cross-functional investigations
Analytical Innovation
- Developed analytical procedures for protein characterization, release and stability testing
- Implemented first multi-attribute monitoring (MAM) method for QC release testing
CMC & Regulatory
- Authored technical sections for 3 biologic drug submissions (CTD Module 3)
- Managed analytical method , validation, and specifications sections for regulatory dossiers
Leadership
- Led team of 15+ scientists in analytical sciences
- Fostered culture of innovation and continuous improvement
- Led cross-functional teams to implement process improvements and enhance operational efficiency.
Analytical Development Specialist
Sanofi
01.2019 - 01.2021
- Responsible for development and implementation of LC-MS methods for the characterization of recombinant proteins
- Streamlined N-glycans control by developing a unified LC method, replacing multiple legacy procedures
Doctorate Researcher
University of Liège
01.2015 - 01.2019
- Developed of liquid chromatography and mass spectrometry tools in support of biomedical and clinical research
- Supervised analytical testing execution for GMP contract testing
Education
Ph.D. - Pharmaceutical Sciences
University Of Liège
Liège10-2019
Bachelor And Master - Pharmaceutical Sciences
University of Liège
Liège09-2015
Skills
- 10 years in pharmaceutical QC, R&D method development, and GMP lab management
- Quality control expertise for biologics
- Expertise in analytical method development and validation
- Leadership in innovative analytical solutions
- Regulatory submission expertise
Languages
French
Bilingual or Proficient (C2)
English
Advanced (C1)
Dutch
Intermediate (B1)
Timeline
Chromatography and Mass Spectrometry Team Lead
Sanofi
06.2021 - Current
Analytical Development Specialist
Sanofi
01.2019 - 01.2021
Doctorate Researcher
University of Liège
01.2015 - 01.2019
Ph.D. - Pharmaceutical Sciences
University Of Liège
Bachelor And Master - Pharmaceutical Sciences
University of Liège