Jessy Vandekerkhove Email & Phone Number

Reykjavik, Iceland

Activities: Gene therapy / Biosimilar QC/ Molecular biology / Quality Assurance GMP, GLP❗ Performed and reviewed the analytical method testing (Potency and related impurities testing), and managed activities within QC laboratories, to ensure continued compliance with GLP and cGMP ✔ Participated in method transfer and / or validation of analytical techniques, particularly in molecular biology ✔ Planned and performed multiple, complex routine/ non-routine methods and procedures ✔ Junior team members Trainer ✔ Participated in the generation and update of SOP’s in accordance with the appropriate regulatory requirements

Reykjavik, Höfuðborgarsvæðið, Islande

Activities: Gene therapy / Biosimilar QC/ Molecular biology / Quality Assurance GMP, GLP❗ Managing and performing analytical method testing (ELISA, Residual DNA, cell-based assays), and activities within QC laboratories, to ensure continued compliance with GLP and cGMP ✔ Participated in method transfer and / or validation of analytical techniques, particularly in molecular biology ✔ Planned and performed multiple, complex routine/ non-routine methods and procedures ✔ Junior team members Trainer ✔ Participated in the generation and update of SOP’s in accordance with the appropriate regulatory requirements

Évry-Courcouronnes, Île-De-France, France

Activities: Cell therapy / Cellular biology / Quality Assurance GMP, GLP❗ Launched the scaling up of production and differentiation of Induced human pluripotent stem cells (hIPSC)using the CliniMACS Prodigy® Instrument for clinical trials ✔ Performedculture and passage in Flask and Cell-Stack of adherent cells ✔ Differentiation into 3 types of cells ✔ Selection of differentiated cells ✔ Phenotypic analysis using flow cytometry

Cestas, Nouvelle-Aquitaine, France

- Prepared and controlled purchases

Shanghai City, China

Cellular & molecular biology / Immunology / Chemistry / Microbiology / Company strategy / GMP, GLP❗ Led a new plant project consisting of designing and opening of a GMP analytical control laboratory: internal laying out and operating practices: ✔ Setted up of safety, security quality and environmental procedures ✔ Negociated with local and international vendors❗ Transferred Knowledge of analytical controls: ✔ Written and managed of standard operating procedures ✔ Written of analytical reports❗ Managed of an international team with 3 laboratory technicians

Dozulé, Basse-Normandie, France

Cellular & molecular biology / Immunology / ISO, COFRAC (French accreditation)❗ Screened of viral equine illnesses to mandatory (EVA, EIA, Dourine) ✔ Performed cell isolation / RNA extraction / qRT-PCR / Neested RT-PCR / CFT / ELISA❗ Metrology manager assistant: in charge of critical equipment monitoring

Gif-Sur-Yvettes

Immunology / GMP, GLP❗ Implemented of controls on products resulting from manufacturing for customers❗ In charged of pipettes management: Qualification / Metrology and training

Laboratoire De Santé Animale, Umr1161

Cellular & molecular biology / Immunology / ISO, COFRAC (French accreditation)❗ Screened of viral equine illnesses to mandatory (West-Nile virus) ✔ Worked under BSL3 condition and in a controlled atmosphere zone (Icube) ✔ Performed VERO cell isolation / RNA extraction / qRT-PCR / Neested RT-PCR / ELISA

Villejuif

Gene therapy / Cellular & molecular biology / Immunology / Chemistry / Microbiology / GMP, GLP❗ Guarantor of lentiviral vector production technics: USP / DSP / fill & finish methods ✔ Worked in a GMP controlled atmosphere area (grade C and grade A in B) ✔ Performed culture on HEK293T cells / Transfection / Transduction / qPCR / ELISA ✔ Written of Standard operating protocols, batch records and manufacturing reports❗ Directed of the company's cryogenics site

Paris Area, France

Cellular & molecular biology / Immunology / ISO, COFRAC (French accreditation)❗ Worked in controlled atmosphere area P2+ and P3❗ Created and managed of virus banking❗ Quality manager assistant: ✔ Updated of standard operating protocols ✔ Monitored of procedures ✔ Validity of methods ✔ Monitored of CAPA ✔ Internal audits / External audits

Région De Montpellier, France

Laboratoire de Bactériologie, secteur des Mycobactéries : ✔ Performed bacterial culture in solid and liquid medium. ✔ Performed PCR, MIRU technic and spoligotyping.

Région De Montpellier, France

✔ Performed bacterial transformation for protein production ✔ Performed purification of proteins by affinity chromatography and size exclusion gel ✔ Analysed produced protein by Electrophoresis SDS-PAGE by denaturing conditions ✔ Performed the formartion of crystal of protein using Crystalogenesis method

Licence Professionnelle Biologie Analytique Et Expérimentale, Biology, General

Certificate Of Mnagament, Project Management, Valided

Define its management policy and human resources management

Training, Clinical/Medical Laboratory Science/Research And Allied Professions, Confirmed

Activities and Societies: Flow CytometryFlow Cytometry : basics, theory and practise on FACS

Procédés Aseptiques, Manipulation En Zone Aseptique, Filtration Stérilisante Et Répartition Aseptique, Connaissance Acquise

Activities and Societies: Service de formation A3PManipuler en zone aseptique sous conditions BPF/cGMP

Bts, Bioanalyses Et Contrôles, Obtenu

Baccalauréat, Stl B, Option Bgb, Mention : Assez Bien