Romain Liénard Email & Phone Number

Ghent, Flemish Region, Belgium

Provide strategic GMP guidance to third-party vendors and partners.Define and review quality agreements with external parties.Monitoring of the performances of vendors.Execution of qualification and routine GMP audits of vendors.Conduct or supervise QA activities such as product complaints, deviations investigations, CAPAs, changecontrols, batch records review, product release.Support mock recalls.Review of process qualification protocols and reports, method validation protocols and reports, stabilityplans and reports, specification documentation, CoAs, Quality sections of clinical dossiers and BLAs, etc.

The International Society for Pharmaceutical Engineering brings together more than 20 000 pharmaceutical professionals from 90 countries around the world. The Emerging Leaders committee consists of young professionals working in the life science industry and together we strive to provide a platform for knowledge sharing and networking within the life science industry, having a positive impact on young professionals early in their careers.

Lessines, Région Wallonne, Belgique

Led a QA Operations team of 14, including coaching, and recruitment.Served as the primary quality representative for Purification activities, ensuring regulatory compliance.Integrated the QA Ops team onto the shopfloor to enhance communication and collaboration.Oversaw batch records review to ensure product quality and consistency.Managed deviations and change controls, aligning processes with quality standards.Supported internal and external audits, emphasizing quality and regulatory compliance.Provided quality support for strategic site projects, from conception to execution.

Lessines, Région Wallonne, Belgique

SME in downstream antibody/protein purification and filling processes.Led investigations using Six Sigma/DMAIC methodologies for process improvement.Authored study protocols and reported results with precision.Monitored yields and process parameters to optimize productivity.Implemented strategies to mitigate risks and ensure operational continuity.Provided cross-functional training on scientific and technical topics.

Lessines, Région Wallonne, Belgique

Acted as a back-up for the manufacturing manager, ensuring operational continuity.Facilitated the transition of an A1PI drug purification line from project to routine production.Coordinated peripheral manufacturing activities (maintenance, validations, EM, shutdowns).Led quality investigations, identifying issues and implementing solutions.Implemented CAPAs to improve production quality and processes.Developed lean and digital tools to enhance team efficiency.Monitored KPIs to optimize production line efficiency and productivity.

Mons, Belgique

Developed innovative synthetic routes and improved procedures for cyclic polymer preparation.Created a mass spectrometry protocol for assessing cyclic material purity.Evaluated cyclic materials' physico-chemical, biological, and biomedical properties for potential applications.Authored 8 peer-reviewed publications, including 5 as the lead author.

Mons, Région Wallonne, Belgique

Led practical lab sessions in Organic Chemistry and Polymer Science for 5-20 students.Provided supervision to help students understand complex scientific concepts and improve lab skills.Conducted student evaluations and offered feedback to support academic progress.

Mons, Région Wallonne, Belgique

Supervised 4-10 researchers within the Polymer department.Conducted training on Good Laboratory Practices (GLP) and Health, Safety, and Environment (HSE) standards.Mentored undergraduate and graduate students on complex research projects.Managed chemical and disposable inventories for efficient lab operations.Acquired advanced lab equipment, optimizing budget for research enhancement.Ensured compliance with environmental regulations for waste treatment processes.

Région De Nouvelle-Orléans, États-Unis

Participated in an International Expertise Exchange Program for global collaboration.Conducted research on biodegradable polyesters, advancing sustainable materials.Research on the development of cyclic polyrotaxanes under the supervision of Prof. Scott M. Grayson.

Ph.D In Chemistry, Polymer Science

Elaboration of cyclic biodegradable polyesters and characterization by mass spectrometry

Master In Management, Magna Cum Laude

Analysis and improvement of the standard costing process in a pharmaceutical company

Msc. In Chemistry, Organic Chemistry, Summa Cum Laude

Preparation of cyclo-based polymeric structures by triazole post-functionalization

Bachelor'S Degree, Chemistry

Cess, Sciences/Mathematics