In Vitro Diagnostics Development and Validation
Expert freelance
ISO 13485 – 2017/746/EU – 21 Cfr 820 – 510k – 2021/808/EU
Noreddine Aggoun Baeyens
Freelancer experiences:
Birth : 01/04/1973 Brussels
Nationality : Belgian
Adress : 15 rue Georges Villers
1367 Ramillies, Belgium
Current
“AI trainer on LLM platform”
↑02/2025 Outlier.ai (US)
Prompt engineering.
Prompt Reviewer – Oracle member –
Email :-Mobile Phone :-
03/2025
“Research and development Senior consultant freelance”
↑12/2024 Arbor assays (US)
LinkedIn
Production and development trouble shooting
Process optimization
Bio-conjugation and enzymatic reaction on ELISA assay Dev.
Specialist
In Vitro Diagnostic Development
and Validation
Languages
French (Native)
English
Educational and professional experiences:
2024
↑2019
Transversal team responsible of all technical aspects of lateral flow
development activities.
Define and drive validation experiments and protocols (R&D)
Audit and validate feasibility and validation steps (R&D/QC/QA)
Write and define QC methodologies and documents for Stab exp. (QA)
QC and production troubleshooting support (QC/QA)
Ensure ad equation activities with QMS (QA)
Deutch
Softwares
Microsoft Suite:
MiniTab (stats)
HTML / PHP / R
2019
↑2016
NCCLS / CLSI EP
2016
↑2004
21 Cfr 820
“Production Development Team Leader”
Unisensor S.A (BE)
Validation Guide Line
ISO 13485
“Technical Excellence Team Leader”
Unisensor S.A (BE)
2021/808/EU
Development and transfer of new LFIA (dipstick) assay in food security.
Define and drive validation experiments and protocols (R&D)
Report and validate feasibility and validation steps (R&D)
QC methodologies and documents (QA) / troubleshooting (PROD)
“Senior development scientist in IVD”
ImmunoDiagnostic System LTD (IDS PLC) (BE/UK)
Development of new Immunological assay kits and Reagent for bioassay
automated (IDS iSYS platform)
2017/746/EU
2004
↑1998
juillet 2024
1/2
“PhD in Science : (Chemistry / Structural Biology and Bioinformatics) ”
“Université Libre de Bruxelles” (ULB) in S.F.M.B Lab (structure and
Function of Biological membrane)
In Vitro Diagnostics Expert
Knowledge
Way of work
“La statistique est l'art de
dépouiller les chiffres de toute la
réalité qu'ils contiennent. " Un"
égale "un", parfois ; le plus
souvent : 1 = x.”.
-Rémy de Gourmont.
« Well done is better than well
said ».
-Benjamin Franklin.
Bio assay development and Validation:
Certification
GLP / GMP certified (CefoChim)
Management Prince2 Foundation certified
Management
Technical
Adaptative
Based on feedback
Profil optimisation
Summary
« I’m a Chemist expert in
monoclonal antibody and
receptor applied to Bio assay
development for EU and US
market. »
Radio Receptor Assay : RRA for IVD ISO 13485 (2010/227/EU-98/79/CE)
Enzymatic Immuno Assay : EIA, IVD ISO 13485, FDA 21 CFR 820, 510k
Luminescent Immuno Assay : LIA, IVD ISO 13485, FDA 21 CFR 820, 510k
Lateral Flow Immuno Assay : LFIA ISO 9001, 2021/808/eu
Protein purification: Affinity , Reverse phase , Ions Exchanges
Protein structure characterization: ATR-FTIR , CD , Electrophoresis
Antibody functional characterization: BLI on Octet system, ELISA
Protein quantification : UV/VIS , ELISA, Bradford
Statistic
Design of Experiment (DoE) under Minitab (screening, optimisation,...)
Descriptive statistic under Minitab and Excell
Hypothesis statistics under Minitab (t-test, ANOVA,..)
Publication / Abstract / Achievements:
Hobbies
Esport
My family
juillet 2024
2/2
Etude topologique de l'atpase gastrique par Aggoun Noreddine
ISBN-10 :- ISBN-13 :- ASIN :- Collection :
OMN.PRES.FRANC
Baeyens N, Wattiez R, Raussens V, Ruysschaert JM, Goormaghtigh E.
(2001), Structural modifications in the membrane-bound regions of the gastric
H+/K+- ATPase upon ligand binding, Eur J Biochem-
N. Baeyens*, A. K. Barnes*, G. Pirens*, G. Sarlet*, M. Bougoussa*, J. V.
Leblon*, M. L. Garrity*. Development of a Bone Specific Alkaline Phosphatase Assay
on the IDS Automated Analyzer 3X3. Immunodiagnostic Systems (IDS) Ltd, Bolton,
United Kingdom. ASBMR 30th annual meeting abstract book (2008) p190.
Noreddine Baeyens, Immunodiagnostic Systems Limited (IDS), Belgium,
Alex Barnes, IDS Ltd, United Kingdom, Martha Garrity, Development of a fully
automated Bone-specific Alkaline Phosphatase assay on the new IDS iSYS automated
analyser. IDS Ltd, United Kingdom. ASBMR 31th annual meeting abstract book
(2009).
In Vitro Diagnostics Expert