Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic
Gwenaël NYS

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
Liège
10-2019

Bachelor And Master - Pharmaceutical Sciences

University of Liège
Liège
09-2015

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

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Gwenaël NYS